Introduction
A biobank or biorepository is an organization that is responsible for the collection of tissue samples for research to improve the understanding of disease, health, diagnosis, and therapy. Along with the samples, they also collect associated data such as family history, lifestyle, age, gender, etcetera to provide some context for the biospecimens. In most cases, the samples are kept for many years depending on the requirements of study for long-term research. With consent, researchers can also track the health of these participants based on past and future medical records. Due to the invaluable biospecimens provided by biorepositories, a comprehensive supply chain is required. These biospecimens are also highly sensitive to changes such as temperature and other storage conditions due to their live and complex structures. Close monitoring is also required to ensure that it remains stable and viable. Depending on the biorepository involved, some offer:
• Liquid nitrogen-equipped vehicles
• Purpose-built facilities
• A global network of experts in logistics for the transport and storage of biospecimens
• A management system that allows their customers to access the inventory and associated data online
Biorepository
For the success of every biobanking project, sample integrity is essential. Many unwanted pre-analytical variables can be introduced during the processing of a sample, ranging from the time of collection, transport, processing, storage, and even during retrieval for analysis. Maintaining the integrity of the biospecimens are crucial for a biorepository. For example, since the temperature is critical for the viability of tissue samples, cold storage units should be monitored around the clock for humidity and temperature. A backup system that provides an uninterruptible power supply should also be in place in case the primary system fails such as in a power outage. A monitoring system that notifies the personnel in case of temperature deviation should also be in place.
Services Provided
Since a biorepository plays a crucial role in providing high-quality samples, some of the services that the biorepository provides include:
a) Cold Chain Services
This includes moving biospecimens, cell therapies, Investigational Medicinal Products, and cell lines ranging from ambient to cryogenic temperatures. This enables the biorepository to distribute and manage the samples effectively without compromising the quality of the biospecimens. Their staff should be trained to ensure that products and samples are packed, labeled, distributed, and stored within the recommended temperature in compliance with strict standards. Due to new challenges from regulations, cost pressures, sustainability initiatives, and competing priorities, the distribution network is increasingly complex. A good biorepository should invest in proper cold chain storage to handle their distribution capability as this mirrors the evolution of the industry to handle increased quantities of cold chain biologics in compliance with various regulations.
b) Validation
Since many variables can affect the temperature of biospecimens throughout the various processes, a good way to prevent this from happening is to ensure that the software and equipment used are compliant with the requirements throughout the custodial chain. To meet the quality standards, qualified equipment and validated processes are of critical importance. Biorepositories can also help evaluate and test the equipment used to ensure biospecimens maintain their integrity. This service can become important for those who are purchasing and installing a new unit, relocating a unit for transfer or requiring shutdown of the system, starting a new project that requires a dedicated unit, experienced an event that may have compromised a unit, and for those who observe anomalies in their unit.
c) Laboratory Processing
Biospecimens are invaluable as they help to advance scientific research. This is why laboratory processing of these biospecimens is crucial to provide an accurate and timely analysis of these samples. Since the quality and integrity of biospecimens are important to ensure that the results of the research are reproducible, every precaution should be taken to maintain the highest quality of tissue samples. Key laboratory capabilities should include blood fractionation, automated sample processing, and nucleic acid or protein analysis and extraction.
d) Kit Production
Since the success of any research or study begins during the collection of biospecimens, a streamlined collection process can improve the quality of samples and cells. This will also help establish a strong foundation for information. Some biorepositories produce kits to allow their customers to put their focus on their research by helping to standardize the aspects of sample handling starting from collection, administration, till the stage of analysis. Biorepositories can design and produce kits that contain all the necessary information, instruction, and equipment needed for technicians to collect and obtain a specimen. These kits can also be produced to enable technicians to administer investigational treatment in compliance with the regulations. On average, it has been estimated that about 13% of biospecimens are contaminated during the collection process. By using these kits, the collection process can be standardized and helps to control pre-analytical variability.
References:
Biologics management. Fisher Clinical Services. Accessed 10/10/2019. https://www.fisherclinicalservices.com/en/services/biologics-management.html?AG=72404276330&KW=%2Bbiobanking
