The standard definition for tissue procurement is the administration procedure of acquiring tissues or organs for transplantation through various programs, systems, and organizations. Organ harvesting or tissue harvesting typically involves a surgical procedure and is especially relevant in the areas of molecular diagnostics.
Why is Tissue Procurement Important?
Tissue procurement is designed to help meet the ever-increasing demands indicated by a growing number of clinical researchers. Biospecimens used for analytical processes can come from diseased or non-diseased surgical, PMI, or autopsy donors. The applications prove to be invaluable in the field of molecular diagnostics. It is within this regard that we are seeing human tissues and cell -culture help to redefine how we solve medical dilemmas such as advanced disease and more effective treatment modalities.
Understanding cell mechanisms of action prove to be one of our most useful advantages due to a modern shift within the biotech community. This also includes advancements in the preservation and related services helped in part by the strategic partnering with biorepositories to oversee tissue procurement procedures and storage. There are various methods of tissue preservation and a full range of biospecimens in which to order, complete with customizations.
Geneticist is a full-service biorepository that offers:
Maintaining a comprehensive tissue database
Providing histological staining and pathological review
Overseeing regulatory compliance
Coordinating clinical trials indicators and patient consent
Tissue Preservation Methodology
Frozen - Frozen tissue is snap-frozen in LN2 or frozen in cryo-embedding media such as OCT and stored at liquid nitrogen or -80° C temperatures until shipped.
Fresh - Fresh tissue can be minced or intact and placed in transport media of choice or saline and shipped for next day arrival.
Fixed - Provided in a fixative of choice or as paraffin-embedded blocks. Stained or unstained slides can also be provided from either paraffin blocks or as frozen sections. Fixed tissue can also be provided in a customized specified preservative, fresh or subsequently frozen.
Tissue Microarray slides are also available.
Tissue Procurement and Regulatory Considerations
The FDA has put in place a strong regulatory focus upon three general areas:
1) limiting the risk of transmission of communicable disease from donors to recipients
2) establishing manufacturing practices that minimize the risk of contamination
3) requiring an appropriate demonstration of safety and effectiveness for cells and tissues that present greater risks due to their processing or their use.
FDA regulates human cells or tissues intended for implantation, transplantation, infusion, or transfer into a human recipient. These are referred to as human cells, tissue, and cellular and tissue-based products. One of the main areas of research is related to cell culture. Their applications have expanded deep into the scope of drug discovery and other relevant therapeutic interventions.
How Does Human Tissue Contribute to the Pharmaceutical Industry?
Helping to establish viable cell cultures is how we investigate the physiology and biochemistry of the cell. We can also determine the effect of various chemicals or drugs on specific cell types. This serves to examine the possibility for specific drug resistance which helps create more improved drug types and overall efficacy.
The tissue procurement procedure most often occurs at the time of operation and it can be tested at the time by pathologists, or it can be preserved at which point the genetic material can be extracted and tests against gene-chips. The information gathered is used in both a diagnostic and prognostic capacity such as assessing likely clinical progression.
A few of the major functionalities of using cell lines are so that we can use them for generating artificial tissues and to synthesize valuable biological compounds from large scale cell cultures such as in the case of developing therapeutic proteins. Using cell lines offer a few advantages in the way of providing consistency and reproducibility of results. It is important to note that cell structure can be altered and they also continue to grow. Cells are able to adapt to different culture environments by varying the activities of their enzymes. Special attention must be paid to successfully recreate the growth mediums of the original microenvironment.
Conclusion
Tissue procurement process is one of the many integral steps to the overall research and development cycle for the pharmaceutical landscape. The donor process has undergone some mainstream refinements to help manage safe specimen practices in an end-end structured format. Targeting avenues to help avoid tissue contaminants continues to be a primary focus. However, strict SOP adherence paired with effective regulatory controls contributes to efficiency in the overall tissue procurement process.
References:
https://dctd.cancer.gov/NewsEvents/20190415_new_tissue_procurement.htm
https://science.howstuffworks.com/life/cellular-microscopic/cell.htm
https://www.ncbi.nlm.nih.gov/pubmed/17889099
https://www.fda.gov/vaccines-blood-biologics/tissue-tissue-products
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4089439/
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3341241/
https://www.lifegift.org/tissue-donation-process
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4724782/
