The Support Biospecimen Collection Offers Biomarker Research Efforts

Recently, biospecimens have definitively gained their place as essential building blocks for advancing biomedical research. However, there is still some lack of understanding of their full potential, regulatory requirements, and collections design. Biopharmaceutical research is progressing and becoming more sophisticated. At the same time, biosample collection is growing more complex. Considering earlier collection projects, we can better understand the critical role collections play in advancing biomedical research, especially how biomarker development can help meet unmet medical needs.

Biospecimen Procurement Challenges

Precision medicine requires being able to identify informative and specific biomarkers. Biospecimens are a critical component of discovering, developing, and validating biomarkers. Precision oncology’s hurdles can mostly be tracked back to biosamples used for research purposes. Solving the challenges with biospecimen procurement will directly address many of the limitations faced during the research and development processes. One challenge that must be addressed is the lack of geographical and ethnic diversity in biospecimen collection. One solution is to expand the geographic presence and network of clinical sites. Another aspect affecting biospecimen collection efforts is the fit-for-purpose element. Procuring samples insists that there be a deep understanding of the current trends in research and how they may be reflected in procurement requests for biospecimens. Trends should be analyzed annually to gain insight and understanding.

Analysis of Previous Biospecimen Collection

It’s equally important to analyze collection processes. For instance, many projects collect matched biospecimen sets. Matched specimens are numerous samples taken from a single donor. The classification of the biospecimens may differ, meaning biospecimens may be obtained from blood and PBMCs, blood and tissue, etc. Or it may be the same type of biospecimen obtained at different times or conditions, such as pre or post-treatment, pre or post-surgery, etc. Additionally, it may be the same type of tissue, such as blood or solid tumor tissue, just stored or processed in a different way. For example, collected solid tissue may be in FFPE and flash formats, PBMCs and plasma samples, or in FFPE and fresh tissue samples. The increased requests for matched biosamples such as these indicate a new sophistication in biomedical research.

For many biobanks, the requests for matched sample collections commonly consisted of solid tumor tissue matched with a patient’s blood sample. This latest trend in biospecimen collection aligns with the latest increase in interest in liquid biopsy test development. The goal is for scientists to find ways of accurately detecting and measuring tumor signatures through a simple patient blood sample. This may also explain why blood plasma is one of the most requested biosamples.

Trends in Biospecimen Formats

Researchers are interested in various preservation formats, depending on the specifics of the research project. Recently, the complexity of combinations is trending. This is likely due to the increase in complexity of biomarker studies. The most requested formats include matched blood and tissue collection, FFPE from tumor tissues along with normal adjacent tissue FFPEs, and blood plasma and PMBCs. Cancer research is reaching for answers, and success depends largely on biospecimens and samples. The three most popular tissue types used for cancer research are colorectal, lung, and breast.

Sample Collection and Urgent Oncology Needs

According to recent statistics provided by the World Health Organization, cancer is one of the leading causes of death globally. The most common new cases of cancer in 2020 included:

·         Breast cancer with 2.26 million new cases reported

·         Lung cancer with 2.21 million new cases reported

·         Colon and rectum cancer with 1.93 million new cases reported.

Research increases in areas of breast, lung, and colon cancers, and much of the results rely on quality biospecimen availability.  This explains the uptick in the number of biospecimen requests. One issue with the research efforts thus far is the lack of projects requesting ethnicity data. Raising awareness of this issue is paramount as scientific research advances. Improving the sensitivity and specificity of lung cancer liquid biopsy tests are urgently needed. Lung cancer remains the most lethal cancer around the world, but it is also typically in the late stages before it is detected. Other types of cancers are detected easier in earlier stages. To date, there are only two FDA-approved liquid biopsy tests for lung cancer, which further stresses the urgent need for more efforts in this area.

Final Thoughts

Biospecimen collection is essential to modern scientific research and is helping medical research advance faster than ever before. Biobanking and specimen collection are changing rapidly in response to increasing demands. Personalized medicine and treatment options rely on the advancement of biospecimen research.

Resources:

https://www.who.int/news-room/fact-sheets/detail/cancer

https://www.cancer.gov/types/lung/research

https://www.mdanderson.org/cancer-types/lung-cancer/lung-cancer-research.html

https://www.cancer.org/cancer/colon-rectal-cancer.html

https://www.roche.com/stories/liquid-biopsy-in-oncology#:~:text=The%20non%2Dinvasive%20nature%20of,be%20analysed%20for%20tumour%20DNA.

https://molecular-cancer.biomedcentral.com/articles/10.1186/s12943-022-01543-7

Biobanking and its Role in Revolutionizing the Medical World

The world around us is constantly being transformed by scientific discovery. Traditionally, the term biobank was used to describe the biorepository that stored biological tissues. Today, that context is broadening. The biobanks store more information than ever before. A biobank continues to store human tissue, but many are moving to more specialized storage. Biorepositories focus on disease-based biospecimens, genetic material, specimens of endangered species, and non-human materials. Defining biobanking in such a broad sense opens up a new world of possibilities for researchers dedicated to studying both human and non-human populations.

A New Era of Medicine

As the biobank expands, so does the medical world. There are many new fields and disciplines offering countless possible applications. In today’s modern medical world, patients, researchers, and health professionals work together more in order to gather new insights. These new insights are used to develop new types of diagnosis and treatment options. Biobanks are one example of the recent shift in modern research methods. There are different biobanking efforts on a global scale, including institutional, national, and international biobank settings. Biobanks are helpful when studying complex diseases such as diabetes, cardiovascular disease, and cancer. This information becomes invaluable when it can be linked it patient information included in medical records and questionnaires. The biobanking industry has benefited from post-genomic analysis, computer and bioinformatic development, and human genome sequencing.  

A New Face of Biobanking

Biobanks house extensive stores of human biological materials. Agriculture, drug development, and medical research contribute valuable information about plants, microbes, and animals. Ecology biobanks contribute to the accessibility of these and other types of biosamples. The diversity of materials stored in biobanks is revolutionizing personalized medicine because of the increased ability to share data. Genetic and biological data are not stored in a single lab, which allows researchers access to greater amounts of data that can be shared with other researchers.

Research and Biobanks

Biobanks are fulfilling an important role in helping to advance research and improve healthcare delivery. A biobank makes high-quality, well-characterized, and related biosamples and data available for research analysis. Therefore, to meet current growing demands, biobanks must create a greater capacity and improve informatics capabilities. Human biological samples stored in cryogenic facilities can revolutionize medicine by giving researchers access to the information they need to study the relationship between disease and genetics. Each year, researchers and scientists save lives through biobanking which allows them to investigate diseases.

Biobanks are an invaluable source of data for genomics, therapeutic target generation, metabolomics, molecular epidemiology, and proteomics. When used as a tool, biobanks significantly contribute to medical research, help with the understanding of disease etiology, translation research, and the advancement of public health. Data continues to become increasingly important for medical researchers as they continue to expand their thinking past traditional medicine and possibilities. Samples and data need to be collected and administered from numerous sources. Big data refers to computerized technologies and software developed and designed to extract knowledge from large amounts of heterogeneous data, including biological data. In fact, computer-based mechanisms are necessary to achieve such a high-velocity capture, discovery, and process. Big data requires different parameters which directly impact biobanking, including data analysis and storage requirements.

Final Thoughts

The further development of the biobanking infrastructure is expected to play an important role in the growth of scientific knowledge, which will transform the world. Biobanking impacts how we understand human health, personalize medicine, develop medications and treatment options, and much more.

https://pubmed.ncbi.nlm.nih.gov/29412882/

https://www.researchgate.net/publication/322040130_Biospecimens_and_Biobanking_in_Global_Health

https://www.cdc.gov/coronavirus/2019-ncov/lab/lab-biosafety-guidelines.html

https://health.ucdavis.edu/biorepositories/pdfs/sustainability-financial-biobank/Sustainability-in-biobanking.pdf

https://health.ucdavis.edu/biorepositories/pdfs/sustainability-financial-biobank/Sustainability-in-biobanking.pdf

How Biobanks and Technology are Helping to Improve Patient Care

Who can measure the rapid rate at which biobanking is improving? There are more biological samples being collected on a global scale. This allows biobanks around the world to create higher quality and quantity data sets. The natural response is a global biobanking market that is also rapidly expanding. Right now, as the Digital Age is in full bloom, biobanks are given a larger capacity for growth. With modern technologies like telehealth, data analytics, and automation more available, it just makes sense. Biobanks that choose to use the latest technological advancements can help create a domino effect that helps to improve patient care.

Automation to Reduce Costs

Biobanks have the capacity to store samples for decades. But as the biobank’s cache increases, it becomes harder to collect, process, store, preserve and distribute samples. Powered by AI, artificial intelligence, automated biobank storage systems can work independently of human input. These automated systems can ensure consistent attention to all the details, even the manual, repetitive tasks. Automation is also beneficial for helping to improve traceability, as well as retrieval and delivery speed of samples. This ensures researchers get them when they need them. This can also help prevent human error in the processes. This is one way automation can help lower the operational and delivery costs of biobanking.

Data Analytics that Improve Research Efforts

Traditional means of analyzing samples is more difficult partly due to the rapid growth of biobanks. Researchers need advanced tools so they can glean more valuable insights from biobanks. And that is precisely where data analytics comes into play. Similar to automated tools, data analytics can make use of AI to examine and analyze samples. The process is much quicker and more accurate than humans and their analytical tools. Machine learning can even help with conducting predictive analytics. Researchers who combine biobank samples with predictive analytics will be able to detect current patterns as well as predict future ones.  For example, using thousands of available images, researchers may be able to predict the likelihood of an individual developing type 2 diabetes or coronary heart disease. This information can be used to implement effective preventative patient care.

Boosting Telehealth Access and Convenience

As biobanks institute the use of automation along with data analytics, the entire medical sector can reap the benefits of reduced costs and improved research outcomes. This will eventually cascade down to the end customer in the healthcare world: the patient.  Patients are already experiencing the benefits of telehealth. It’s more affordable, convenient, and personalized than traditional care. These benefits can be amplified by healthcare companies that choose to use biobank-powered research in effective patient care.

Some of the benefits of telehealth include having access to a huge network of clinicians who cover more diverse treatment areas. It allows more opportunities for collaboration between healthcare providers and companies. This is important to patient care in an era when people are more desiring of healthcare that is both convenient and accessible.

Final Thoughts on Biobanking and Healthcare

Biobanking seems to be flourishing just as modern advancements are making epic progress. The combination of the two can help improve modern healthcare. Professional collaborations are working together to create new techniques and treatment strategies that may revolutionize universal health and healthcare. The domino effect of these collaborations is only going to work to improve patient care in the long term.

References

https://www.scidev.net/enterprise/data/

https://www.drugtargetreview.com/article/42538/realising-the-promise-of-laboratory-automation-in-biomedical-research/

https://www.biorxiv.org/content/10.1101/2020.01.15.897066v1

https://www.ddw-online.com/automated-biobanking-the-next-big-step-for-biorespositories-1039-200708/

What the Rapid Growth of Stem Cell Banking Means to Medical Research

Stem cells are one of the most promising and rapidly emerging areas of research. The latest scientific advancements are behind the rapid growth. As stem cell research rises globally, biobanks are being created to meet the demands. Biobanks preserve the characteristics of stem cells, prevent contamination, and facilitate their use for biomedical research.

Stem cells in the human body are “unspecialized.’ Both embryos and adults contain them. They are also known as “seed cells” and “universal cells” because of their potential to self-renew and their multidirectional differentiation. Some experts refer to them as a “life bank” since the cells can be collected, prepared, and stored so they can be used for ongoing research.

Biobanking and Stem Cell Research

The collection and use of different biological materials is not a new occurrence. It’s been going on and fueling research for many years. More recently, advancements in stem cell research has increased the need for stem cells and stem cell lines. This is a therapeutic need. Stem Cells are classified by scientists based on their ability to differentiate into other types of cells. There are five types of stem cells based on their potential differentiation, including:

·   Multipotent Stem Cells

·   Oligopotent Stem Cells

·   Pluripotent Stem Cells

·   Totipotent Stem Cells

·   Unipotent Stem Cells

Researchers continue to explore the potential of stem cells in a variety of approaches. They are useful for drug discovery, toxicology, developmental biology, regenerative medicine, and cell therapy. Some stem cells are derived from tissue that only happens once during a lifetime. Traditionally, cord blood was discarded, but today, it is used to treat many diseases like blood cancer. Biobanks can store and preserve stem cells for long periods of time. Then, they are available when needed for treatment or to prevent the progression of a disease.

Scientists and researchers anticipate using stem cells and their ability to differentiate in many fields. The hope is that they can provide substantial improvements in fields such as biochemical studies, gene therapy, and regenerative medicine. These advancements include transplanting cells and tissue to effectively treat diseases. However, to achieve the full potential there has to be stem cell repositories that make stem cells available for further research and study. Even if they are used for treatment purposes, storage options must be available.

Benefits of Preserving Stem Cells

Stem cell preservation is essential for their use for medical purposes. When properly preserved, stem cells can be moved from one site to another. Preservation also allows safe and proper testing. Preserving stem cells provides some notable benefits.

· The stem cells in one’s body can be used to treat a wide range of diseases.

· When compared with bone marrow, cord blood contains more stem cells. In most instances, collecting stem cells from cord blood is not difficult and presents no danger of hurting the mother or baby.

· Currently, there are about 80 life-threatening disorders and diseases that can be treated using umbilical cord blood stem cells. These include blood disorders, genetic disorders, cancer, and immune system disorders.

· When stem cell therapy is needed, a perfect match is instantaneously available through stem cell banking. This saves a lot of money and time.

· Embryonic stem cells derived from a baby can treat an adult or another infant.

Stem cell research is a fascinating and innovative field, and it continues to grow rapidly. The cells are demonstrating a therapeutic potential for treating many different diseases that were once thought to be incurable. Since stem cells can create new tissue and cells, they are beneficial for treating a wide range of disorders and diseases. Here are a few examples of diseases that have been treated with well-preserved or stored stem cells.

Regeneration of Human Tissue and Organs

Using stored stem cells helps regenerate tissue and organs. There is a great need of organs, including skin tissue. Organs can be regenerated, donated, and transplanted in cases of organ failure.

Treating Type I Diabetes

Type 1 diabetes occurs when pancreatic cells do not function properly and fail to produce enough insulin. Using preserved stem cells allows pancreatic stem cells to be transplanted into type 1 diabetes patients. Patients whose insulin-producing cells have been destroyed by their immune systems may benefit from replacing the damaged cells with new stem cells.

Treating Cardiovascular Issues

Most cardiovascular disease is created by problems with blood vessels. One team of researchers at a Massachusetts hospital produced new blood vessels from stem cells. These particular cells resembled natural blood vessels in both function and appearance. Stem cells from a biobank can be used to regenerate or repair different tissues in humans. They are beneficial for helping manage vascular and cardiovascular diseases.

Treating Brain Disease

Many neurological disorders are often associated with cellular loss following injury. Stem cells can be used to treat these types of disorders. Parkinson’s, for example, leads to loss of control of muscle movement because of damage to brain cells. Researchers use stem cells to restore brain tissue that has been damaged by Parkinson’s disease. The new brain cells may prevent the uncontrolled movement of muscles.

Final Thoughts on Stem Cells

Stem cell research is making great headway almost every day. Their wide range of applications and benefits drives the need for more availability. Biorepositories must rise to meet the procurement and storage needs to make them more widely available to help advance medical research and the development of treatment options.

References

https://www.mayoclinic.org/tests-procedures/bone-marrow-transplant/in-depth/stem-cells/art-20048117

https://www.isscr.org/

https://www.sciencedirect.com/science/article/pii/S1873506122002306

https://www.stanfordchildrens.org/en/topic/default?id=what-are-stem-cells-160-38

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4264671/

Importance of Ethnic Diversity in Biospecimen Collections

Understanding how each patient is unique is key to precision medicine. Individuals from the same ethnic origin or geographical population have genetic features in common. This leads to variances in how different populations respond to therapies and drugs. Discovering and developing personalized treatments requires analyzing a variety of patient samples that represent natural genetic variability. Ensuring ethnic diversity in biospecimen collections is essential, especially in the early preclinical stages of developing a treatment or drug.

One issue that must be dealt with is obtaining samples that are genetically diverse and geographically distinct. Ethnic diversity needs to be part of essential research from the beginning. Most patient-derived samples are obtained from primarily Caucasian donors.

The biopharma field has continued to achieve amazing results over the last few decades. However, drug development is still risky, costly, and a lengthy process with many treatment options never making it all the way to the market. To try to bypass these types of issues and ensure efficacious healthcare continues, both the pharmaceutical and scientific communities must find sustainable solutions. Take, for instance, how geographical and ethnic disparities in biomarkers and cancer incidence are reflected in both clinical and early-stage studies.

Cancer Biomarker Expression and Geographical Disparities

The goal of personalized medicine is to oversee and treat diseases based on the genetic and molecular signature of each patient. This is well-settled as the future direction of modern medicine. But it stresses the importance of considering genetic diversity when assigning treatments. Preclinical and clinical research needs to consider various patterns that are characteristic of a specific population and then ensure the pool of individuals represents the populations that are expected to use the tested drug.

When it comes to cancer, evidence continues to support the significant differences in cancer biomarker expression, incidence, and mortality rates, and the response to a specific therapy among ethnically and racially diverse populations. Lung cancer, for example, is associated with the highest mortality rates associated with malignant diseases. Over the last few years, many successful therapies targeting lung cancer mutations have evolved. Even though this demonstrates promising results for many patients, cancer relapse and resistance are persistent issues.

Researchers have recently discovered that lung cancer mutation has a higher incidence in women and patients of Asian descent. But some studies have also revealed that there is a lack of data obtained from lung cancer patients from Central and South America, the Middle East, Central Asia, and Africa. This showcases the critical need for better ethnicity, including in clinical studies. Sadly, this is not an isolated situation. There remains a significant underrepresentation of different ethnic groups in early and clinical-stage research.

Lack of Ethnic Diversity and Data Persists

The NIH Office of Minority Health Research was established in 1990 with the goal of focusing on health disparities. It issued guidelines in 1993 which required government-funded biomedical research to include minorities and women. This has been widely disregarded by the pharma and research communities.  The human genome was decoded in the early 2000s, after which the GWAS (Genome-Wide Association Studies) became a useful and powerful tool by providing enormous amounts of data for biomedical research.

Patient-derived tissue samples and cell cultures are the basic disease models used starting in the earliest steps of drug development. Although things are beginning to change, some of the earliest human tissue samples were not accompanied by any records regarding ethnic origins. More research and work are needed to help us understand how biomarkers in an ethnic group may be applied to another. Then, we can evaluate whether genetic and ethnic underrepresentation could possibly be the key to some of the side effects and non-responsiveness often detected in some patients.

Final Thoughts

It’s important that the bio-industry overcome the obstacle of the underrepresentation of geographical and ethnic diversity. But it will need to be understood and implemented beginning at the earliest stages and continuing throughout the latter stages of biomarker and drug development. Scientists and researchers must consider the ethnic origin of disease models. Biobanks must collect information on the background and origin of donors. Medical doctors need to be more involved in clinical and preclinical projects while working towards including patients from a variety of backgrounds. These changes will help biomedical research and ensure future patients will benefit from drugs that are safe and efficient.

References:

https://www.eurekalert.org/news-releases/634130

https://www.ft.com/content/afd0ac7e-fd3a-11e8-b03f-bc62050f3c4e

https://acsjournals.onlinelibrary.wiley.com/doi/10.1002/cncr.32020

https://ascopubs.org/doi/full/10.1200/JCO.22.00754

https://www.breastcancer.org/research-news/minorities-underrepresented-in-cancer-research

https://www.fda.gov/consumers/minority-health-and-health-equity/clinical-trial-diversity

https://pubmed.ncbi.nlm.nih.gov/26609494/

Biobanks Important Role in Investigating the Impact of Genetic Variants on Human Disease

Biological samples are donated by groups of people. These samples are then stored at low temperatures in biobanks and biorepositories. Population-based biobanks have become vital tools in helping to discover disease genes today. Using a biobanking system, multiple diseases and traits are investigated simultaneously. This allows for the discovery of relationships between phenotypes.

Functions of Biorepositories and Biobanks

Biosamples are collected and stored for the purpose of research. Over the last three decades, over 120 biobanks have been established around the world. Although they all perform the essential function of storing biological samples for research, their collections may vary. They range from small biorepositories being maintained by universities to large repositories that are supported by private and governmental organizations. These laboratories collect and store samples as well as provide research information on cellular biology and pathology.

Revolution of Genetic Science

The discovery that many of our most common diseases are multi-factorial has spurred a revolution in genetic science. Thanks to large-scale biobanks, it is possible to access data and tissue from individuals from whole populations. These are beneficial for helping understand the role of genes in disease prevention as well as health development. Biobanks continue to serve as valuable resources when it comes to understanding how genetic factors relate to the outcomes of disease.

Population-based biobanks collect biological tissue from individuals who may not have a specific disease. The goal of creating a genetic database is to analyze DNA. The information obtained helps determine genetic determinants of diseases, both common and uncommon. Generally, biobanks help analyze biomarkers along with lifestyle and medical history. A solitary gene mutation can cause a rare disease. Having this link provides a powerful tool that helps with understanding the role of genetic factors and how they contribute to disease. This information is essential to understanding common conditions such as diabetes, schizophrenia, cancer, and Alzheimer’s disease. It also helps researchers and medical professionals assess adverse outcomes like preterm birth and congenital defects.

Biobanks and Genetic Information

Biobanks can house a huge amount of genetic information. This information is accessible to scientists to use for a variety of research purposes. Various biobanks focus on specific applications that include different genotyping strategies. They each rely on different sample and data sources. Population-based biobanks offer the advantage of providing information about gene or allele frequency in populations due to the large number of participants.

Presently, there is not enough understanding about genomic factors and their role in common diseases to affect public health initiatives or patient care. However, as access to biobanks increases, more information will become available about genetic and modifiable risk factors and eventually, this will be able to contribute to effective disease prevention. The goal is to increase understanding of whole-genome sequencing and deep phenotyping to help prevent many underdiagnosed diseases.

Final Thoughts

Researchers continue to make progress in understanding genetic variants and their impact on disease. Biobanking is essential to move them from the discovery phase into the implementation phase. Of course, this means being able to translate enormous amounts of information into widespread use. No one knows the future for sure, but biobanks seem to be growing into a more prominent tool and they are likely to continue helping provide the tools necessary to investigate health and disease.

References:

https://www.ed.ac.uk/files/atoms/files/real_data_resource_pack_human_genetic_variation_and_disease_v7_21june2016.pdf

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6681822/

https://www.science.org/doi/10.1126/science.abi8207

https://genomemedicine.biomedcentral.com/articles/10.1186/s13073-021-00857-3

Biomarker-Driven Cancer Research Relies on High-Quality Biospecimen Selection

Treatment methods for many diseases and medical conditions are quickly changing. Recent breakthroughs in immunotherapy have proven effective for treating different types of tumors. Biomarker analysis has undergone recent advances that help identify patients who better benefit from immune-oncology therapeutics, as well as helping provide insight into how tumors mutate during disease progression and treatment. Advancements in biomarker discovery, validation, and clinical application hinge on one crucial resource: high-quality biospecimens.

Accessing a consistent supply of quality, deeply phenotyped biospecimens is necessary for professionals and scientists who participate in the ongoing discovery and validation of immune-oncology treatment options, immune checkpoints, and targeted therapeutics for CAR-T cell therapies. Researchers must consider specimen type in order to extract the needed data from biospecimens. This ensures they use the appropriate specimen type to provide answers to the questions they are asking.

The key is developing biospecimen strategies that advance immune-oncology R&D (research and development) that focuses on applications of biospecimens that support biomarker discovery.

Enhancing Program Success using a Robust Biospecimen Strategy

Sourcing Biospecimens for Developing Targeted Therapies

Choosing the right source and quality of biospecimens is a make-or-break deal when it comes to identifying de novo biomarkers as well as therapeutic drug targets. Using quality-controlled biospecimens containing rich disease characterization enables the identification of tumor-associated antigens which leads to successfully developing various targeted therapies. These therapies include monoclonal antibodies, anti-cancer vaccines, CAR-T cell therapies, and ADCs (antibody-drug conjugates).

Guide Therapeutic and Diagnostic Development

When researchers are not able to procure quality biospecimens their therapeutic and diagnostic development programs are more likely to fail. Some programs are unsuccessful because the drug target is just expressed by a subset of patients, or it is also present in healthy patients. Both of these are discoverable early on by comparing biomarker prevalence in severe vs mild, or versus controls. When biospecimen strategies that do not include a powered control group or disease severity characterizations prohibit validation.

Quality Biospecimens in Oncogenic Discoveries

High-quality biospecimens are crucial for identifying novel cancer resistance mechanisms and oncogenic pathways. Research has effectively shown how biomarker expressions change during tumor progression and cancer treatment. Over time, repeated biospecimen profiling provides insight into disease management and helping to develop treatment plans for resistant strands.

Immuno-Oncology and the Role of Biomarkers

There are only a few immune checkpoint inhibitors that have been approved so far for treating patients with different types of cancer. The percentage of patients who respond well to therapies is encouraging further research and development. Because of the positive response to treatment, there is a need for optimizing immune-oncology biomarkers to select patients who could benefit from treatment.

Immune checkpoint inhibitors presently use IHC-based companion or complementary diagnostics to determine the effectiveness and safety of a treatment for a specific patient. Still, other biomarkers may be valuable for sub-classifying the types of tumors and assessing responsiveness. These biomarkers include:

·         Tumor mutational burden (TMB)

·         Microsatellite instability (MSI)

·         Gene expression profile

Invaluable predictive information such as immune function genes, human leukocyte antigen, and inflammatory markers can be determined from some types of tumors. The latest research on molecular and spatial profiling has been able to assess different tumors’ microenvironments. This provides great insight into the distribution of immune cell infiltration. This information is key to learning how effective immune checkpoint inhibitors may be. This type of beneficial information is due to robust biomarker data taken from a wide range of quality biospecimens.

Selecting Biospecimens

FFPE Tissue

Considering the variety of biospecimens, choosing the appropriate specimen type is essential to generating the desired data. FFPE tissues (formalin-fixed, paraffin-embedded) are versatile biospecimens that provide a wide range of applications. They are often used to determine the tissue distribution of a biomarker or antigen of interest. They are also used for genomic profiling. The continued development of transcriptomic technology also allows for gene expression analysis studies using FFPE tissue. FFPE samples of solid tumors are beneficial for epigenetic profiling or molecular and spatial profiling. These studies help bring an understanding of the molecular basis of carcinogenesis.

Liquid Biospecimens

High-quality liquid biospecimens are essential for helping to evaluate biomarkers and to identify potential targets that help shape immune-oncology therapies. One of the most widely used biospecimens in in cancer biomarker research, as well as therapeutic and diagnostic development, is plasma. Plasma proteome provides insights into cancer-induced alterations versus the normal physiological states. Please note that studying plasma can be challenging due to plentiful proteins and their wide, dynamic range of concentrations in plasma proteome.

Some of the most recent technological advancements in mass spectrometry workflows have improved the processes of validating biomarkers. Biomarker discovery has been accelerated due to the reduced reliance on separate immunoassay-based validation.

Peripheral Blood Mononuclear Cells (PBMC)

Peripheral blood mononuclear cells or PBMCs play a huge role in the immune system. PMBCs have been essential in the study of immunological mechanisms and responses. In most instances, they are characterized by quantity, activity, and cell type. They are also accompanied by phenotypic data like the medical history of the patient. For studies seeking to elucidate molecular differences or drivers of different disease severity, these in-depth characterizations are vital.

In vitro and in vivo studies often use PBMCs. Invitro applications include disease modeling and cell function investigations. To study the immune response to malignant tumors, in vivo analyses often involve reconstituting immunocompromised animal models with human PBMCs. They are also used to expand patient-derived T cells in adoptive cell therapy.

Key Takeaways

Much of future biomarker research relies on the use of high-quality biospecimens. Researchers continue to make progress in developing patient-specific treatment solutions. Biospecimens are at the heart of the future of precision oncology.

References

https://www.cancer.gov/research/areas/genomics

https://bmccancer.biomedcentral.com/articles/10.1186/1471-2407-9-409

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7594219/

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4150371/

https://audubonbio.com/blog/cancer-research-depends-on-biospecimens/

Current Challenges and the Future Direction of Biobanking

The medical and research communities are focused on biospecimens. When it comes to the advancement of modern biomedical research, biospecimens are invaluable. However, their use also presents a variety of ethical, regulatory, and technical challenges. Tackling these issues and other risks necessitates an understanding of both the purpose and nature of biospecimen procurement.

Biospecimens are Necessary Components for Biomedical Research

Biospecimens have been considered the latest currency of research. They have played a critical role in both research and healthcare and continue to make a huge impact. The latest developments and future of genomic innovations start with a sample. Obtaining samples for cutting edge research and discovery is linked to the biobank. The future of preventive genomics, personalized medicine, and new treatment options rely on a strong biobanking sector.

Improvements to Patient Centricity

Helping patients is at the center of the healthcare industry. Most recent developments include creating more patient-centric treatment options. One goal for medical researchers to connect patients to the biobanking and sample procurement processes. The biobank plays an essential role and is sometimes the first person patients encounter during research. It may be the first opportunity a patient has to interact with the scientific community. Biobanking needs to be at the forefront of getting the message across to patients as they communicate the value biobanks provide.

Balancing Data Availability and Protecting Privacy

Biospecimens come from human patients. The specimens are accompanied by specific data about the patient including medical, genetic, and personal data. It’s essential for researchers to find the balance between protecting a patient’s privacy and making medical and personal data available. As biobanking changes the landscape of medical research and patient care, it’s important to develop solutions and best practices that help with flexibility and data usage without causing harm.

Collaboration and the Future of Biobanking

There remain some challenges when it comes to biospecimen procurement and biobanking. The need for patient-derived biospecimens is certain to increase. Therefore, the process of procuring them while protecting patients’ data needs to be optimized. It’s important that stakeholders join forces and that there is an improved awareness of how beneficial biospecimens are for developing new therapies. The connection between biobanks and clinical trials is strengthening and becoming more connected with drug development and genomics. Biobanks help close the gaps.

The future of biobanking will require biobank professionals to consider that they are becoming a service-oriented entity. Of course, progress comes with a variety of legal and ethical issues for both non-profit and public biobanks. The challenge for private biobanks is to make their biospecimens available to a larger scientific audience. Crossing fields and industries poses challenges yet the future of biobanking is promising.

Final Thoughts on the Future of Biobanking

Medical researchers rely on the availability of biosamples. Biobanks are under more pressure to procure samples, yet do so ethically while protecting patient privacy. It’s a challenging course, but it is essential for changing the scope of future medical breakthroughs and improving patient treatment options.

References

https://healthtalk.org/biobanking/what-is-biobanking-and-why-is-it-important#:~:text=Biobanking%20refers%20to%20the%20process,Types%20of%20biobanking%20sample%20').

https://translational-medicine.biomedcentral.com/articles/10.1186/s12967-019-1922-3

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8275637/

https://journalofethics.ama-assn.org/article/how-should-biobanking-be-governed-low-resource-settings/2020-02

Biorepository vs. Biobank: What are their Roles?

As the medical community continues to research and study the many facets of disease, it is precipitates significant advancements in prevention, diagnosis, and treatment options. The biorepository, which collects and stores large supplies of biological samples, plays a major role in studies. You may have heard both “biobank” and “biorepository” used interchangeably. According to the National Cancer Institute, a biorepository stores biospecimens. Let’s explore how the two terms have been defined traditionally and consider commonalities and differences.

What is a Biorepository?

The National Institutes of Health (NIH) defines a biorepository as a “library.” It’s a location where biospecimens are stored and available for research or clinical purposes. What is a biospecimen? It is a biological material, including tissue, plasma, urine, or blood. Samples are often accompanied by demographic and medical information. Biorepositories may include specimens taken from a variety of sources, including plants, animals, and humans. The idea is to collect, process, store, and distribute samples so that they can support current use as well as contribute to future scientific investigation.

Four Primary Operations of a Biorepository

A biorepository has four main functions pertaining to samples: collecting, processing, storing, and distributing.

·         Sample Collection – Biological specimens are obtained and then recorded. Recording samples usually involves scanning each sample’s unique barcode, so its information is recorded in the biorepository’s information management system. This information typically includes the sample origin, type, and date it was collected.

·         Sample Processing – The processing phase involves testing and preparing samples for storage. One example is fixating tissue samples to maintain the tissue morphology so it can be sectioned and stained later.

·         Sample Storage – Once biospecimens have been collected and processed, they are stored in the proper conditions to ensure their longevity. Storage conditions are logged into the biorepository’s information management system and include information such as storage date and location.

·         Sample Distribution – The final step in the lifecycle of a biospecimen is distribution. The biorepository fulfills orders or requests from a research team. The sample is retrieved from inventory and sent to the requesting party.

Biorepositories are established based on the type or types of specimens they store and how long samples will be stored. Current biorepositories supply samples used to better understand diseases and to develop prophylactic and therapeutic strategies. Even though the scope and nature of biorepositories vary, they must comply with a set of standardized laboratory guidelines to ensure their specimens’ quality and preservation. Most repositories are reviewed by committees or boards that have an established vetting process used to fulfill sample requests. These entities also oversee a wide range of issues, such as protecting patient information and ethical matters.

What is a Biobank?

Biobanks are types of biorepositories. They contain biological samples that are used for human research. The definition of a biobank is a collection of biological material that is stored in an organized system along with its data and information. Biobanks are categorized by various approaches like disease state, setting, and population. They also vary greatly based on the nature of the specimens they handle, contents, scale, and participants. A biobank may also be classified in several ways based on any of these factors. However, in general, biobanks have two distinguishing classifications:

·         Disease-Oriented: Biobanks containing clinical data and tissue samples.

·         Population-Based: Biobanks focus on the study and development of common and complex diseases.

Biobanks today are a critical resource for scientists. As next-generation sequencing technology continues to emerge and being able to better study pathogen and human genomics for more personalized medicine, biobanks are even more crucial. The specimens and their information stored in biobanks help support the study of cancers, human pathogen interaction, rare diseases, and genetic biomarkers that can all help improve patient outcomes.

Recent Perspectives on the Difference Between a Biorepository and a Biobank

The lines of definition between biobanks and biorepositories have become blurred recently. Originally, the term “biobank” referred to the collection of human biological materials, while the term “biorepository” referred to collections of specimens collected from all living organisms. Since most use the terms interchangeably, it is more difficult to distinguish the two. However, a biobank is focused on communities, whereas a biorepository is focused on a global and future view.

References

https://www.govinfo.gov/content/pkg/FR-2006-04-28/pdf/06-3997.pdf

https://biospecimens.cancer.gov/patientcorner/

https://cdn.ymaws.com/www.isber.org/resource/resmgr/Files/ISBER_Best_Practices_3rd_Edi.pdf

Liquid Biopsies and Their Role in Clinical Trials

Liquid biopsies are testing techniques that analyze blood samples for cancer cells from a tumor circulating in the blood, or they are used to analyze DNA pieces from tumor cells found in blood. There are three types of liquid biopsy methods, including:

·         Cell-free DNA (cfDNA)

·         Circulating tumor DNA (ctDNA)

·         Circulating endothelial cells (CECs)

It’s worth noting that the potential of using cfDNA was investigated as early as 1947. However, cfDNA was first reported when used in a case that detected cancer in a pregnant woman in 2013. In recent years, liquid biopsy techniques using cfDNA and ctDNA have been useful biomarkers useful in determining a diagnosis and prognosis of solid tumors. However, there are some advantages and disadvantages of using liquid biopsies as new techniques continue to emerge in next-generation sequencing.

What are the Advantages of Liquid Biopsies?

Oftentimes, cancers are present in body organs that are difficult to access like the pancreas, ovaries, or brain. Trying to obtain tissue-resident biomarkers from these types of tumors via surgical biopsy comes with an increased risk of infection or bleeding. cfDNA is released directly into the bloodstream by cellular processes that include apoptosis, phagocytosis, autophagy, and proptosis. DNA levels are higher in patients who have cancer. Structural changes in their DNA sequence are observed, which reflects the process of the disease.

One benefit of liquid biopsies is the real-time information on tumors. This is significant since tumors change over time. Being able to detect these variations in real-time positively impacts treatment modifications which can be more beneficial for patients.

Analyzing DNA from traditional biopsies yields information on which cells are predominant in the tumor. Also, tumor analysis on cfDNA provides information on tumor sites so that the disease and progression can be more accurately monitored. Additionally, cfDNA that the tumor releases into the bloodstream carries the same variants as the tumor cells. This sampling is much easier and allows information to be obtained of various types without inconveniencing patients. Obtaining timely information on different cancer cell variations is a powerful resource when designing modern, targeted therapies.

What are the Limitations of Liquid Biopsies?

Some physicians are not yet willing to rely on liquid biopsies as well as other tests. One of the limitations of the liquid biopsy is the variations cfDNA can present between patients. Cancer patients, in particular, have only 0.1 to 10% of tumor-derived cfDNA. The level of tumor-derived cfDNA can depend on numerous factors, including the cancer stage, tumor burden, tumor vascularization, apoptosis rate, and metastatic potential of the cancer cells. This makes it difficult to detect in its early stages.

The use of tissue biopsy is still the standard for confirming and diagnosing diseases including various types of cancer. They are also useful for determining the disease’s characteristics. Presently, liquid biopsy hasn’t yet replaced tissue biopsy testing, but it is used alongside tissue biopsy.

More clinical trial validation is needed to determine the value of liquid biopsies in medical settings. Additionally, more studies are needed to assess testing accuracy and how effective it is at identifying different tumor types. Presently, it is not known if a liquid biopsy provides a satisfactory sampling of genetic clones in a tumor or if there is some bias specific to the tumor’s sub-regions.

Final Thoughts

The liquid biopsy is emerging as a method to monitor treatment and define targeted therapies. While it is less troublesome for patients, the need for further clinical evaluations exists before it can become the gold standard. The cost factor also comes into play and may impact non-profitable institutions profoundly. Even though it has not yet become the standard in clinical practice, liquid biopsy and its further development are making an impact in clinical research.

References

https://www.cancer.gov/publications/dictionaries/cancer-terms/def/liquid-biopsy

https://www.cancer.gov/news-events/cancer-currents-blog/2017/liquid-biopsy-detects-treats-cancer

https://www.ajmc.com/view/the-promise-of-liquid-biopsies-for-cancer-diagnosis

https://www.cap.org/member-resources/articles/the-liquid-biopsy

https://www.nature.com/articles/d41586-020-00844-5

Biobanking’s Role in Promoting Personalized Medicine

With the new era of precision medicine, how the biopharma industry views biobanks is changing. Previously, biobanks were seen just as sites for cold storage of tissue samples. Today, the biopharma industry understands that biobanks are repositories of data and treasure troves of essential and useful information. The shift impacts the developers of biobanking technology.

The benefit of biobanking is enabling healthcare services to reduce their costs on a global level. Ultimately, the goal is for the healthcare industry to move from reactive treatment of symptoms to more proactive healthcare services that treat the cause of the symptoms while taking a preventative approach that delivers better health outcomes. The medical world continues to evolve and tissue storage methods have progressed. The need for increased storage capacity will grow in response. Progressive countries have used biobanks to store cord blood for years. Other countries have been offering it only as a commercial service individually. While the face and role of biobanking are changing, the previous models help enable personalized medicine in the future.

As the global population continues to age, the demand for long-term healthy tissue storage increases. Biobanking of healthy tissue like embryonic stem cells from cord blood can help regenerate damaged tissue. This is most likely going to be the new standard in the near future. Studying stored disease tissue will lead to the discovery of new treatment options.

Cell and Gene Therapy Sector

Another sector increasing the demand on biobanks recently is cell and gene therapy. Recent developments in the use of cell and gene therapies for cardiovascular disease and cancer are likely to put even more demand on biobanking services. Through the use of cell and gene therapies, large-scale drug discoveries are shaping personalized cancer treatments for individuals. As this medical space grows, there will be an increased demand put on biobanking capacity. The World Health Organization attributes the highest mortality rates to cancer, infectious disease, and cardiovascular disease. These three can be characterized more precisely. That would mean that a treatment could be chosen based on the molecular profiles of each individual. Treatment efficacy and patients’ quality of life would be greatly improved. Biobanks can help encourage the growth of the cell and gene therapy sector, thereby promoting personalized medicine and practices.

Biobanking Technological Innovations

Biobanking technology is also evolving with the changing industry demands. Biobanks first emerged in the mid-‘90s, but the term only referred to collections of human samples kept in cold storage. In essence, the “technologies” were just large freezers that maintained ultra-low temperatures. Today, this definition has expanded to include various technologies used to store a wide range of biological materials obtained from various sources. One specific area of research is examining the use of human biomaterials to replace animal models. This places an extra storage demand on biobanks. It’s not as simple as just creating more space to hold samples. The samples are also in greater demand due to the growth of the drug industry. Ultimately, this means the number of deposits and withdrawals of biobanks are more frequent. With such growth, the designs of biobanks have evolved as well.

Technology is being developed at an unprecedented rate as sample loading, archiving, and retrieving must be tracked and traceable. This is necessary to preserve long-term sample integrity. Modern biobanks have automated most of these processes. This is likely to be the focus of future automation and digitization in the biobanks sector.  Technological advancements are needed to enhance freezers, sample monitoring, and robotization in the biobank industry. For instance, digital solutions have shifted from just managing sample location to managing all the data that is related to the sample’s quality. That includes how the sample was handled before storage, who manipulated it, and how the temperature in the freezer changed over time.

Automated Biobanks and Cost Reduction

Biobank automation can help cut costs associated with sample storage and the preparation of samples for analysis. Recently, there have been more funds pouring into biobanking globally. State funds and private support have helped balance out the technological advancements and market demand. This means the cost per sample has decreased even though it varies depending on the region’s regulations. In some countries, biobanking receives full government funding; some charge on individual levels, and some just charge for storing samples. Biobanks have more operational expenses than just sample storage, though. They have to pay a staff, provide consumables, and equipment maintenance as well as laboratory management.

Handling Data-Rich Samples

Until recently, sample information was stored separately. Capacity was one reason since it represents such a large quantity of data. But security and maintaining donor/patient confidentiality were other reasons. But today, thanks to modern technology, content is stored with samples which makes the biobank more of a data bank.

The Future of Biobanking

As biopharma and the medical world lean toward a more personalized treatment approach, the demands put on biobanks are likely to increase. The need for storing more samples from various tissue types will continue to increase. With these trends, the need for more storage capacity will grow as well. Biobanking is likely to play a major role in the future of healthcare by enabling the development of more targeted treatments for patients. Biobanks will be key to creating replacement tissues from stem cell, and creating preventative therapies used early in the disease. This may reduce the overall financial burden caused by some of the present ineffective nonspecific therapies.

The pressure will be on biobanks to develop common methodologies and standards to help keep pace with the collaborative approach of the drug industry. Product development in the drug industry requires much data. There should be more effort between databanks to facilitate data sharing. Creating standards and methodologies may help bundle physical biobanks into a single searchable database eventually.

Final Thoughts

At the emergence of biobanks, the focus was sample collection and storage. As technology, science, and medical sectors expanded, biobanks had to rise to the increased demand. Today, they are perched on the edge of discovery as a contributory factor. They have a lot more to offer the medical world, but that’s no surprise!

Resources

https://www.ncbi.nlm.nih.gov/books/NBK567260/

https://www.frontiersin.org/articles/10.3389/fcell.2019.00246/full

https://www.mdpi.com/2072-6694/12/4/776/htm

https://researchopenworld.com/patient-oriented-biobanking-for-cancer-research/

https://translational-medicine.biomedcentral.com/articles/10.1186/s12967-019-1922-3

Evolution of DNA Isolation from Blood Samples

Blood-based research has soared to a whole new level due to next-generation sequencing, microarray technologies, and PCR. There are numerous applications from whole-genome sequencing, DNA fingerprinting, liquid biopsy, blood banking, and plenty more. No matter what the application, the prerequisite is concentrated DNA extracted from whole blood. It must be pure, double-stranded, highly concentrated, and intact. The technique used for DNA isolation impacts results and the entire workflow of molecular biology research. It’s essential to modern-day research and diagnostics that blood extraction is done properly and efficiently. DNA extraction is crucial to diagnostic and medical research.

Importance of DNA Extraction from Blood Samples

The earliest DNA extraction was performed in the 1860s. But, of course, the methods of extraction have changed drastically since then. What was cutting edge discovery in 1860 is routine today in the world of clinical research and molecular biology. But it was definitely the first step to many downstream applications. Molecular research requires obtaining high-quality and high-quantity DNA. Blood is essential on many levels, from routine health checks to drug discovery. In addition, it provides a wealth of biological information on human diseases and physiology.

Friedrich Miescher Makes the First DNA Isolation

Friedrich Miescher was investigating the composition of white blood cells (leukocytes) in 1869 when he isolated an unknown substance. He noted it behaved differently to proteins in solution. After he experimented with various acidic and alkali conditions, he had actually obtained the first sample of what is now known to be deoxyribonucleic acid or DNA. As a young scientist, Miescher continued to investigate his discovery and develop new protocols. He first separated the nuclei from the cytoplasm, then isolated the novel precipitate.

Development of DNA Isolation Procedure

Even though Miescher published his isolation protocols in 1871, routine procedures for DNA extraction didn’t fully develop until 1958. Meselson and Stahl completed a DNA extraction from bacterial samples. They used a salt density gradient centrifugation protocol. After that, DNA extraction methods evolved to cover a wide range of biological sources. Researchers began to adapt extraction needs, and technology advanced. Using organic and non-organic reagents, DNA extraction methods continued to follow the same steps. Today, the method has been simplified, automated, and performed using DNA extraction kits.

Methods of DNA Extraction from Whole Blood Samples

There are two main DNA extraction method categories solution-based or solid-phase. Solid-phase sample preparation separates DNA from other compounds based on physicochemical properties. Solution-based protocols use a salting-out technique or organic solvents to extract DNA. Several factors should be considered when choosing the extraction method. Factors such as sensitivity, consistency, ease, and speed are important. Equally worth considering is the type of specialized equipment needed as well as the level of expertise required to operate it. For some, the choice is an all-in-one DNA extraction kit rather than using complex machinery.

The Latest Advancements in DNA Extraction: Magnetic Beads

The newest method of extracting DNA is magnetic bead capture. How does whole blood DNA isolation using magnetic beads work? It starts with magnetic beads that are coated with a matrix of silica which binds nucleic acids. As with many chemical methods, whole blood cells are first lysed using SDS or a similar detergent. Next, the lysed cells are mixed with magnetic beads allowing the DNA to bind the beads. After a few rounds of washing, the magnetic field separates the captured DNA from other unbound cellular contaminants. Finally, a low-salt buffer removes the DNA from the beads.

A Few Tips

DNA extraction methods continue to evolve as technology advances. There are still a few possible problems with magnetic beading, even though it is the fastest method. But no matter which method is chosen, things can always go wrong. Here are a few tips to help ensure you get high-quality, genomic DNA from blood samples.

·         Conduct a Pilot Experiment: If you are trying out a new method with lots of blood samples, start small. Perfect and optimize your procedures before spending more money and time further developing the experiment.

·         DNA Preservatives: There are several DNA stabilizing reagents available. Liquid reagents are added to blood samples right after isolation. This inhibits nuclease activity and reduces potential contaminating microorganisms. You’ll be able to store unprocessed blood for longer without worrying about DNA degradation.

·         Quantity DNA Properly: If your DNA preparation contains contaminates in degraded DNA and RNA, it will influence the final results. Using only one method of quantification will not always catch these invaders. It makes sense to use a combination of agarose gel electrophoresis and spectrophotometry to quantify and visualize genomic DNA. This can save a lot of time and money.

Final Thoughts

Advancements in biochemistry, cell biology, life sciences, and biotechnology have made lab work easier. There is pretty much a kit for every process. However, with the advantages and disadvantages, new laboratory techniques are sure to develop. It’s important in your lab that you choose the appropriate path for DNA extraction from whole blood samples.

References:

https://www.cdc.gov/dpdx/diagnosticprocedures/blood/dnaextraction.html

https://www.dovepress.com/methods-for-extracting-genomic-dna-from-whole-blood-samples-current-pe-peer-reviewed-fulltext-article-BSAM

https://www.sepmag.eu/blog/magnetic-dna-purification-history-recent-developments

https://biomedgrid.com/fulltext/volume8/the-evolution-of-dna-extraction-methods.001234.php

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5529626/#:~:text=Magnetic%20Beads%2DBased%20Nucleic%20Acid,via%20complementary%20hybridization%20%5B53%5D.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7080036/

Top 7 Reasons Companies Will Continue to Outsource Clinical Sample Management in 2022 and Beyond

Managing samples is a complex process. Clinical samples are typically collected in various locations before being transported, stored, processed, and analyzed by numerous vendors. There are some downsides to this fragmented approach. Some of the issues include spiraling storage costs, difficulties with data management, poor custody records, and slow transfer times. Here is a look at 10 drivers for outsourcing management of clinical samples.

1. Centralization

Long-term storage of both active and prospective clinical trial samples, regulatory samples, or legacy samples can be centralized. A biorepository vendor is capable of handling many varieties of sample types including:

·         Proteins

·         Cells

·         Viruses

·         Bacteria

·         Animal specimens

·         Tissue specimens

Biorepositories provide multiple storage conditions for different types of specimens. This centralized storage approach has benefits including easy identification of sample location, minimizing delays in sample handling, and simplifying vendor management.

2. Improving Speed

Oftentimes, biopharmaceutical companies move clinical trial samples to long-term biorepositories after the completion of a clinical trial. Samples may be stored at a variety of specialty laboratories, or at external biorepositories. But if the company has to retrieve the samples quickly, it can take weeks. A delay in retrieval can impact the outcome of a study in a major way. For this reason, it’s crucial to identify a partner who can offer timely sample retrieval.

3. Reducing Costs

Sample storage costs are calculated as part of a clinical trial budget. Unfortunately, once the study has ended, sample storage continues to be charged to the budget instead of clients. This makes it easy for a client to miss associated invoices and expenses. Outsourcing sample storage allows total access to samples and provides expense visibility which greatly reduces the costs.

4. Quality Assurance

Identifying a quality management system is crucial. They should meet the stringent diagnostic sample and GxP requirements. Integrated lifecycle management platforms manage vendor relationships and utilizes standardized sample handling processes. This ensures sample quality and integrity.

5. Mitigating Risks

Outsourcing protects sample and data assets by carefully monitoring and secure temperature-controlled facilities. Repositories should feature numerous redundancies, enduring business continuity, and pro-active risk management systems.

6. Logistics

The keys to successful logistics include storage experience, shipping, and tracking to ensure sample integrity, and proven risk mitigation strategies to keep irreplaceable assets secure. Also crucial for sample management are the maintenance of chain of condition, chain of custody, and chain of identity.

7. Flexibility

Engage with experts who provide flexible enhanced storage solutions. They should provide efficiency, integrations, and should be tailored to fit specific needs. Biorepositories can help customize clinical sample storage requirements by offering onsite, offsite, virtual, and hybrid storage solutions.

Final thoughts on Outsourcing Sample Storage

Good storage practices are essential to the integrity of every study. By outsourcing sample storage to reliable sources, it ensures the study’s smooth progress from beginning to end. Sample retrieval processes should not be complex or time-consuming as researchers need access to samples in a timely fashion. Outsourcing can provide the flexibility, logistics, and speed needed for successful research projects.

Resources

https://www.who.int/ihr/training/laboratory_quality/5_b_content_sample_mgmt.pdf

https://www.news-medical.net/whitepaper/20210617/What-is-sample-management.aspx

https://www.precisionformedicine.com/clinical-trial-services/clinical-sample-management/

https://www.titian.co.uk/en-us/the-essential-guide-to-managing-laboratory-samples-web

The Important Role Human Serum Plays in Research

There are some good reasons why human serum is one of the most important tools in the world’s laboratories today. Scientists use human serum to grow human cells, more deeply understand the immune system, test the efficacy of drugs, and perform innovative research. Processing human serum for research purposes is complex, but it provides a product that can be used for reliable, repeatable results.

Serum Sample Collection

There are more than 4,000 components in human blood. Each one has a different purpose. The blood’s major components include red and white blood cells, platelets, and plasma. Plasma makes up about 55% of the blood with the other 45% being cells. White blood cells fight infection. Red blood cells carry oxygen. Plasma is a clear, but yellow-tinted watery fluid that holds platelets and cells. It also holds lipids, enzymes, proteins, antibodies, hormones, minerals, vitamins, and blood-clotting factors.

After blood is drawn from donors, lab techs place it in a centrifuge to separate the plasma and the cells. Then the serum is separated from the plasma. The composition of human serum and plasma are similar except for the clotting factors. These are necessary for clotting to occur, especially fibrinogen. Once the lab separates the plasma and human serum from the whole blood, the plasma will retain the fibrinogen, but the serum will not. What does this mean? It means the serum has no clotting ability. It cannot coagulate since it doesn’t contain fibrinogen.

The Makeup of Human Serum

Even though human serum contains no fibrinogen, it does contain carbon dioxide, proteins, minerals, and hormones. Albumin is one of the important proteins found in human serum since it carries steroids, thyroid hormones, and fatty acids in the blood. Serum is also an important source of electrolytes.

The Role of Human Serum and Medications

 It is human serum that allows substances to stick to molecules found in the serum. This effectively binds the substance to the blood. This is what allows the transporting of thyroid hormones, fatty acids, and other substances in the serum. It works as a circulating carrier which is why drug manufacturers design medications that bind to proteins like albumin. Once a medication attaches to the albumin, it carries it throughout the bloodstream so that it reaches the target organ or tissue. For example, the curable substances in antibiotics bind to albumin in human serum which is how they are carried throughout the body.

How Human Serum is Used

Researchers use animal serum when they can, but in some cases, it’s not an appropriate substitute. For example, cancer therapy studies and DNA research require the use of human serum samples. Scientists use human serum as a supplement added to culture media since human cells typically require human serum rather than animal serum to grow properly.

Immunity Testing

Human serum yields excellent results when culturing most types of human cells, but particularly for cells associated with the body’s immune system. Researchers use human serum along with lymphocyte culture media. This supports the growth of dendritic cells and lymphocytes which play roles in immunity. Human serum is used by researchers in immunohistochemical staining procedures. This process helps identify foreign antigens that trigger immune responses.

Organ Transplant Compatibility

Yet another use for human serum by scientists in in human leukocyte antigen (HLA) tissue-typing applications. These test the compatibility of donor and recipient organ transplants.

Human Serum in Metabolic Studies

Human off-the-clot serum is used for metabolic studies. Laboratories collect off-the-clot serum by allowing whole blood to coagulate naturally. During this natural process, the blood is not exposed to anticoagulants. Then, a centrifuge is used to separate the serum from cellular components. The serum is then allowed to go through another clotting process. This second clotting by the serum ensures all clotting components are removed. Laboratories centrifuge the serum specimen again, and then draw off the remaining serum which is packaged according to the requirements of the researcher.

Cell Therapy

AB serum is useful in investigating cell therapy applications, tissue engineering, and transplantation. Human AB serum is collected from donors who have AB blood type. It lacks antibodies against both A and B antigens.

Final Thoughts on Human Serum

Human serum is used for research in laboratories around the world. It’s important for scientists to have access to serum samples so they can continue innovative research strategies. Their research is key to discovering new drugs, procedures, and therapies that help improve human health.

Resources

https://pubmed.ncbi.nlm.nih.gov/22230555/

https://www.frontiersin.org/articles/10.3389/fphys.2014.00299/full

https://www.sciencedirect.com/topics/biochemistry-genetics-and-molecular-biology/human-serum-albumin

https://www.pharmaceuticalprocessingworld.com/fda-zika-virus-guidance-plasma-protein-products/?utm_source=TrendMD&utm_medium=cpc&utm_campaign=Pharmaceutical_Processing_World__TrendMD_0

https://www.pharmaceuticalprocessingworld.com/fda-approves-pathogen-reduction-system-to-treat-plasma/?utm_source=TrendMD&utm_medium=cpc&utm_campaign=Pharmaceutical_Processing_World__TrendMD_0

https://www.pharmaceuticalprocessingworld.com/fda-approves-kcentra-for-the-reversal-of-anticoagulation-in-adults/?utm_source=TrendMD&utm_medium=cpc&utm_campaign=Pharmaceutical_Processing_World__TrendMD_0

4 Challenges of Effective Biological Sample Management

The cornerstone of successful clinical trials and research projects is safely transporting, handling, and storing biological samples. However, there can be many challenges when it comes to ensuring biosamples are kept safe, preserved properly, and organized. Improperly managing biospecimens can result in mixed up samples or even missing samples. These types of errors resulting from mismanagement can drastically alter a clinical trial’s outcome. This often leads to higher costs. Unusable samples, data loss, and other problems are entirely preventable. Here are four challenges often associated with biospecimen management and how to overcome them.

Challenge 1: Transporting Bio-Samples Globally

For some clinical trials and studies, biological samples are often collected from around the world. They just need to be stored in a single safe location. If you need to choose a biological sample management provider, make sure they can handle global sample transport. Make sure the biological sample provider has proven experience as transporting samples safely requires specific expertise and knowledge.

Challenge 2: Compromised Sample Security and Safety in a Biorepository

When you collaborate with an experienced biological sample management provider, you greatly reduce the risk of compromised or misplaced samples. A reputable repository will prioritize sample safety, security, and integrity.

Challenge 3: Small Sample Storage Projects can be Expensive

Sometimes, larger sample management services don’t have the capabilities to provide custom storage solutions. They are not prepared for projects that have smaller storage needs. They accommodate, but oftentimes charge a premium price to store samples. Or they offer another expensive option of managing samples in-house. A repository should offer competitive pricing as well as custom storage solutions.

Challenge 4: Managing Samples is Often Time-Consuming

Not only can it be costly but managing biological samples can also be time consuming for lab technicians and scientists. Sometimes, lab techs do not have the capabilities for managing bio samples. Working with a bio sample management expert can help streamline the process and free up time for research and other related tasks.

3 Tips for Improving Biosample Management

There’s no doubt that research teams spend a lot of time and effort collecting biosamples. They are the basis for research and will be for years to come. It’s important to have them readily accessible, preserved, well-documented, and easily managed. It’s not adequate to just stash tubes, plates, and trays of RNA, DNA, tissue, protein, cell lines, serum, urine, or plasma in a freezer. That just won’t work for a long-term storage option. Here are three expert tips for better managing specimens whether you manage them in-house or partner with a biobank.

Plan, Plan, Plan

There’s no doubt you are aware of the protocols for experiments and research projects before running them. You have everything all ready. You have every step planned out so the integrity of the project is not compromised. Planning ahead includes designing the study and collecting biological samples. This means planning the collection of samples, storing and preserving them, as well as how you plan to use them.

Label, Document, & Track

Data management best practices include closely monitoring samples from the cradle to the grave. Everything bit of information is important, and everything needs to be labeled, documented, and tracked. There are numerous software options that make data management efficient and thorough. But it can also be done on spreadsheets or in notebooks, as long as it is done.

Biobanking

It’s a good idea to consult with a repository whether you need to archive samples for your own use or want to share them with the scientific community. A biorepository can assist with sample procurement, management, and storage.

Final Thoughts

Even though managing biological samples has plenty of challenges, there are ample solutions to consider. Ultimately, it’s about finding the processes that work best for specific situations and circumstances for your lab, clinical study, or project.

References

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4779093/

https://www.americanlaboratory.com/913-Technical-Articles/30828-New-Best-Practices-for-Biosample-Management-Moving-Beyond-Freezers/

https://www.news-medical.net/whitepaper/20211202/What-Should-You-Look-for-When-Choosing-a-Biobanking-Sample-Management-System.aspx

https://www.liebertpub.com/doi/10.1089/bio.2011.0050

https://www.who.int/ihr/training/laboratory_quality/5_b_content_sample_mgmt.pdf

The Important Role Human Tissue Variations Play in Breast Cancer Research

The National Breast Cancer Foundation reports that more than 250,000 women receive a diagnosis of breast cancer every year. Of the one in eight women who battle breast cancer, about 16% will die from the condition. Even though it is less common in men, still about 2,500 men are diagnosed with it each year.

One reason breast cancer becomes so deadly is the high risk of it spreading to other areas such as the lungs or the liver. It is also difficult to research since there are many challenges when attempting to extract tumor cells from the source. However, researchers are able to conduct some very promising cancer research using various types of human tissue samples. The hope is that more hope can be offered to those who fight to treat and defeat the disease.

The Role of Stem Cell Signaling

Human tissue specimens provide the basis for studying stem cell signaling and it is helping to change how scientists understand the disease. A glandular ductal network makes up the mammary gland. Current theories suggest the terminal ductlobular unit is where breast cancer begins. Using human mammary gland tissue from both females and males allows scientists to study the epithelial cells lining the ducts.

Stem cells in the mammary glands play a huge role in developing breast cancer later in life. Stem cells remodel breast tissue during different life changes like puberty and menopause. The stem cells communicate with a type of immune cell (macrophage). This communication may be how the disease gets its start as well as how it spreads to other parts of the body.

Use of Human Tissue Variations

Evidence has indicated that just one breast stem cell in mammary gland tissue is able to self-renew and grow into a fully functional mammary gland. It may be true for breast cancer stem cells as well. Scientists use human tissue samples from various organs to study notch signaling. Using what they know about cancer stem cells, they can apply the knowledge to other organs such as the pancreas, brain, and liver. Combining stem cell signaling with tissue types helps study the various pathways of both pre-invasive and invasive breast cancers.

Benefits of Biospecimens in Cancer Research

Scientists rely on high-quality human bio-specimens to research many types of cancer. Labs around the globe use human tissue samples like liver, brain, skin, mammary, placenta, and many other types too. By using human tissue samples, researchers can target research and conduct specialized molecular tests to better understand how disease begins, grows, and spreads.

Final Thoughts

Without human tissue samples, the hope of beating various types of cancers is diminished. Cancer kills millions of people every year. Early detection is one of the best ways to increase survival rates of deadly cancers like brain, colon, and breast cancer. Research professionals look for enhanced screening mechanisms as well as genetic markers that could indicate a person is at risk. Without biospecimens, this life-saving research is not possible.

References

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC138780/

https://breastcancernow.org/breast-cancer-research/breast-cancer-now-tissue-bank/about-tissue-bank

https://www.cancerresearchuk.org/about-cancer/breast-cancer

https://medicine.iu.edu/research-centers/breast-cancer

https://www.wcrf.org/dietandcancer/breast-cancer-statistics/

The Future of Precision Medicine and the Use of Human Biospecimens

Innovation continues to drive the advance of precision medicine. The latest powerful tools include genomic sequencing, artificial intelligence, wearables, and electronic health records. Technological advances provide huge steps forward in the field of medicine, but how are we supposed to put them all to work? How do we get the most out of them and use them to enhance precision medicine? At present, researchers work on a global platform to find detailed answers to these questions.

The Need for Precision Medicine

There’s no doubt that the medical industry has made huge strides over the last decade. But in spite of all the advancements, like developing COVID-19 vaccinations, there is a need for precision medicine to move further, faster. Human biospecimens play an important role in conducting precision research and development.

7 Areas Precision Medicine Must Focus On

Huge Longitudinal Cohorts

Biomedical databases help aggregate patient data on genes, lab results, and lifestyles. It’s simply not possible to extract these insights and biomarkers from smaller samples. If this data is made available to researchers, it can be standardized so it’s more easily shared. Then it can be collected into a single database from which everyone can work. A huge cohort would have a huge impact on global research efforts.

Big Data and AI

Until the most recent decade, researchers haven’t had access to solid datasets so they could analyze them. The good news is that this is rapidly changing. The growth of clinical data, molecular technologies, and the availability of wearable devices help provide high-resolution data streams that expand the availability of environmental and detailed phenotype data that was not available on such a large scale.

Routine Clinical Genomics

Today, there is limited use of clinical genomic sequencing. It is mostly used in specific cases such as rare genetic diseases and certain cancer cases. Many genomic tests are only looking for a few genetic markers. As precision medicine advances, a whole-genome approach will become more routine. It should be one of the earliest steps to help understand, prevent, detect, and treat both common and rare diseases.

Electronic Health Records

Electronic health records (EHR) are commonplace today giving access to mounds of data to patients, doctors, medical professionals, and researchers alike. In one study, the participants had on average over 190 clinical notes, over 700 lab tests, and 14 radiological studies over an 8-year period. If this information source can be combined with routine genomic sequencing, it can yield decades of data for research.

Diversity and Inclusion

Having more diversity in research studies would offer numerous benefits including addressing disparities and yielding risk stratifications. Presently about 85% of the participants in clinical trials are white. Having more diversity in clinical trials and in the life sciences workforce should deliver better research results.

Phenomics and Environment

Wearable devices can prove invaluable. Most of a person’s life isn’t spent in the health care system. Integrating information from wearable devices into other patient-provided information could be a huge plus and enable wider telehealth capacities. Wearable devices have been improving since the onset of their use and can more accurately track metrics like oxygen saturation, physical activity, heartbeat, and environmental exposures. Some of the latest devices are able to link with restaurants and grocery stores to provide new information on dietary habits.

Return on Value

Participants can be provided something tangible of value in exchange for providing their data for the advancement of precision medicine.

Final Thoughts

Presently, it seems each of these seven areas is progressing rapidly. But if it can all be pulled together to help with the advancement of precision medicine, it will make it easier to reach and maintain health goals. The end goal of course, is to enhance processes used for detecting, preventing, or treating diseases more effectively.

Resources

https://medlineplus.gov/genetics/understanding/precisionmedicine/definition/

https://obamawhitehouse.archives.gov/precision-medicine

https://www.cdc.gov/genomics/about/precision_med.htm

https://www.fda.gov/medical-devices/in-vitro-diagnostics/precision-medicine

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5101938/

Human Lung Tissue and Modern Respiratory Research

Even if you are not a respiratory researcher, you may be rather impressed by the efficient working of the human lungs. On average, the lungs weigh less than three pounds altogether, yet healthy individuals take about 17,000 breaths a day. It is a natural step for researchers to look at human lung tissue as they explore treatment options and cures for common respiratory diseases.

Importance of Biospecimens of Human Lung Tissue

Biospecimens of lung tissue provide researchers with samples to study lung diseases on both the molecular and cellular levels. Recruiting tissue donors isn’t such an easy process. However, to be able to analyze and research medical interventions on behalf of patients whose lungs are diseased or failing is imperative.

Research continues on a global level as researchers dedicate themselves to discovering ways to keep the lungs healthy longer as well as learning how to help regenerate lungs that have started failing. Where do these biospecimens of human lung tissue come from? Many times, it comes from patients who are getting ready for lung surgery. Patients often agree to allow surgeons to collect blood and tissue from what would typically be discarded after surgery. Most patients are suffering from COPD (chronic obstructive pulmonary disease), interstitial fibrotic lung disease, or idiopathic pulmonary fibrosis. Some suffer from other conditions such as pulmonary hypertension and cystic fibrosis. Of course, samples are only taken from patients who give their consent.

Studying Human Lung Tissue Samples

A whole team of professionals works together once a sample of human lung tissue is secured. Together, they glean as much information as possible. Lab techs, data coordinators, and radiologists all play a role in assessing the human lung tissue. When possible, they study live tissue samples as it provides insight into what happens as the tissues start to break down. The goal is to discover ways to prevent the breakdown from occurring. The more tissue donors, the better it is for researchers who are studying the various stages of lung diseases. Having access to human lung tissue taken from healthy adults provides an important comparison. By analyzing the different types of lung tissue samples, researchers hope to be able to find the point lungs become diseased so they can try to head it off.

Why the Study of Lung Tissue is Important

The NIH (National Institutes of Health) places great importance on the study of lung tissue. Currently, about 20% of all deaths can be linked to lung disease. Lung disease is likely to reach the third leading cause of death and disability soon. Lung tissue research is needed to be able to better predict diseases before symptoms begin as well as discovering and designing new treatment options.

The good news is that the respiratory community has recently made great progress in pulmonary science. There may not be just a single reason for the progress, but it is certain that having access to lung tissue samples plays a large and important role. Researchers find the answers they need by studying lung tissue at the molecular level. Recent advances in molecular biology are redefining pulmonary diseases. Just one example is that molecular markers are now useful for diagnosing respiratory infections, antitrypsin deficiency, and cystic fibrosis. Without access to lung tissue, none of this would be possible.

Final Thoughts

There remains much to learn from respiratory research and human lung tissue samples continue to play a large role. Through the study of tissue, the scientific community can learn more about the many different causes of lung diseases. With this invaluable knowledge, preventing respiratory diseases can take huge steps in the right direction as well as the discovery of effective treatment options.

Resources

https://www.who.int/health-topics/chronic-respiratory-diseases#tab=tab_1

https://erj.ersjournals.com/content/46/5/1270

https://www.sciencedaily.com/releases/2021/10/211020135905.htm

https://www.novartis.com/diseases/respiratory-disease-research-novartis

The Important Role Biobanking Plays in Modern Medical Research

The term, “biobanking” refers to the practice of collecting biological samples including blood, bone marrow, urine, spinal fluid, saliva, and tissue. Samples are used for research to gain more understanding of health and disease. Biobanks serve as a biorepository that collects, processes, stores, and supplies specimens and data for clinical and research investigations.

History of Biobanking

Biobanking began about 30 years ago at a small university. It was established for specific studies but has now grown and evolved significantly. Although biobanking began as a storage option for basic biological samples, facilities have grown to be sophisticated entities that are parts of larger infrastructure networks.

Role of Biobanking Today

The medical field today has entered a new age for patients, healthcare providers, and academic institutions as these entities now bring results together to advance in detecting and treating a wide array of diseases. As it stands today, biobanking plays a significant role in the field of biomedical research. Biospecimens are preserved in numerous biobanks around the world. Researchers continue to develop new techniques and strategies for detecting the origins of disease and seek to provide more personalized options for treatment.

Currently, many large-scale biobanking initiatives continue on national, international, and institutional levels. Biobanks provide exceptional resources for researching many complex diseases like cancer, diabetes, and cardiovascular disease. Combining biobank resources with questionnaires and medical record data is vital to the improvement of population health by making medicine customized and more effective.

Biobank Advantages

It’s difficult to put a value on biobanks and biorepositories. Every year, lives are saved by the infrastructure that enables scientists and researchers to investigate diseases. Many life-threatening diseases have been either significantly reduced or completely eradicated through these efforts. Biobanks are an invaluable resource for modern science when it comes to genomics, metabolomics research, therapeutic target creation, proteomics, molecular epidemiology, and biomarker and drug finding. It’s not really much of a surprise that industry and academic researchers have a growing interest in biobanking.

Oncology and Biobanking

Cancer biobanks use a sophisticated system to store cancer samples and data that are used on a global scale. They are used for cancer prevention, diagnosis, detection, and treatment.  Cancer biobanks are on a route to revolutionize research, advance genetic studies, and identify future drug targets.

Cardiovascular Disorders and Biobanks

Cardiovascular disorders, like cancer, are a large cause of death and morbidity in adults and children alike. Recent breakthroughs in cardiology research have led to the discovery of some possible proteins and genetic biomarkers. Biobanks are a valuable resource for cardiovascular research and help lead the way to diagnose and treat cardiovascular disorders.

Biobanks and Pandemics

Biobanks have played a useful role in the recent COVID-19 pandemic as well. Samples stored and retrieved from biobanks have enabled researchers they need to research and study the coronavirus and develop vaccines.

In Conclusion

Biobanking is having a remarkable impact on health sciences worldwide. Samples are used on a wide scale from small operations to larger, complex enterprises. They are playing a role in paving the way for the personalization of medicine and treatment.

References:

https://www.biobanking.com/author/admin/

https://www.liebertpub.com/doi/abs/10.1089/bio.2014.0061

https://febs.onlinelibrary.wiley.com/doi/full/10.1016/j.molonc.2008.07.004

https://www.reumatologiaclinica.org/en-biobanks-their-importance-in-clinical-articulo-S2173574314001038

https://pubmed.ncbi.nlm.nih.gov/20680423/

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7275812/

Improving Biosample Management Methods

It’s likely that your team spends a lot of time and effort collecting biosamples. They are the basis for your research and for others as well. It’s likely that biosamples will be used in research for many years to come. It’s important to ensure that they are readily accessible, easy to manage, preserved properly, and of course, well documented. Sure, you’ve considered plenty of long-term storage possibilities. Stashing tubes, plates, and arrays of RNA, DNA, plasma, urine, blood, tissue, cell lines, or protein in a freezer isn’t the best plan. Here is some expert advice pertaining to long-term storage and management of biosamples.

Planning for Now and Later

Experiments in any industry or field need adequate preparation to be successful. Obviously, you and your team need to make sure you understand protocols before running an experiment. You’ll need to have EDTA-coated collection tubes, a bucket of ice nearby, and ready reagent in tubes ready to receive tissue samples. It’s also essential to know if the samples will be used immediately, aliquoted, or preserved for later use. All containers need to be appropriate for the application they will be used for. For example, can the vial handle liquid nitrogen? Every item needs to be labeled appropriately.

Permissions and Forms

A second area that requires great effort in planning is permissions. You’ll need patient consent forms if applicable to IRB (Institutional Review Board) consent forms. All of your clinical data needs to be linked to physical samples. However, you’ll also need to re-identify it. Best practices when handling biosamples is to rename items as it’s not recommended to have patient information or protocol information on the sample container or tube.

Designing Studies and Collecting Samples

Proper planning in regards to designing studies and sample collection help make them useful over time. Of course, you want to think about sample collection for your activities today, but don’t forget to plan for opportunities that may exist tomorrow. One example includes using cryopreserved peripheral blood mononuclear cells as a standby insurance policy. PBMCs are often kept on hand in case a lab runs out of DNA. PBMCs can be used to make a cell line if needed. When labs first began this practice, they had no idea how valuable it would be for inducing pluripotent stem cell lines in the future.

Labelling Documenting, Tracking

It’s not difficult to find standard operating procedures, checklists, or best practices for procuring and storing samples. The College of American Pathologists and the International Society for Biological and Environmental Repositories are both great resources. Even though the processes are not difficult, they do require training, well-maintained and monitored equipment, and data management. The most useful archives will include a well-documented chain of custody from the beginning to the end. Of course, this will include the protocol and patient information, but it will also include:

·         Who procured the sample(s)

·         When the samples were procured

·         How the sample was processed

·         How much time it took to travel from patient to freezer

·         Which freezer the sample stored in

·         Where the sample is stored in the freezer

·         Temperature of the freezer

·         Any deviations

Biobanking Samples

Consulting with a repository about the various aspects of sample procurement, management, and storage is a great resource. They are helpful whether you are archiving samples for your own projects or planning on sharing them with the scientific community. Some research facilities hire and train personnel to use the necessary software and equipment. Others let a biobank do a lot of the work for them. Outsourcing is a great option, especially when space is limited. But it can also be helpful for backups.

 Final Thoughts

It doesn’t matter how extensive or modest your biosample storage needs are, you can learn from those who have gone before you. Proper preparation can not only preserve the integrity of the biosamples you have on hand presently, but it can be a valuable move even as we move into the future.

References

https://www.clinigencsm.com/a-guide-to-biological-sample-management

https://www.americanlaboratory.com/913-Technical-Articles/30828-New-Best-Practices-for-Biosample-Management-Moving-Beyond-Freezers/

https://www.bioprocessonline.com/doc/standardizing-biosample-management-why-use-collection-kits-0001

http://www.stem-art.com/Library/Biobanking/Biosample%20Collection%20final%202014.pdf

https://pubmed.ncbi.nlm.nih.gov/18406002/