So interesting to get this question now! I just presented at a cell and gene therapy symposium and learned a lot from those colleagues (cell viability experts).
Here are the standards that already exist:
1. USP 1044 Cryopreservation of Cells - https://www.usp.org/sites/default/files/usp/document/our-work/biologics/resources/gc-1044-cryopreservation-of-cells.pdf
2. ANSI/PDA Standard 02-2021: Cryopreservation of Cells for Use in Cell Therapies, Gene Therapies, and Regenerative Medicine Manufacturing - https://www.pda.org/bookstore/product-detail/6498-pda-standard-02-2021
Please see if any of this information could be helpful to your colleague.
Thank you.I hope this info helps!Suzin Webb
I don't wish to seem vague in responding, but answers to your questions can be widely different based on what you are storing and what is the anticipated use. Tied to those factors is also your mission and/or goals.
For instance, our program is primarily a 'prospective procurement service' as opposed to a straightforward biobank. We have a high utilization rate (80% +). We only bank samples that are rare specimens or that we know are likely to be used even though we don't have an active protocol at the time of collection.
We perform an annual audit to determine if we need to cull samples. We make those decisions based on many factors including (but not limited to): storage time; number of aliquots; sample size; number of similar samples types; preservation type (FFPE, -80, -20, OTC, etc.); available storage space; trends in science, etc.
QC is done on samples shortly after the time of collection and samples that fail QC are destroyed quarterly. QC audits are performed on a small percentage of samples that have been stored for long term (>5yrs). There's a decent amount of literature out there indicating that stable storage conditions will allows samples to be stored for very long periods.
So in the end, decisions on storage time go back to what are you storing and why. And I also agree strongly with Sara – no one really wants to discard anything... if you have enough space.
If you have specific questions, join the biobank community and we can discuss in more detail.
Diane (Dee) McGarvey, QBRScm
Director, CHTN Eastern Division
ISBER Director-at Large, Americans Region
Department of Pathology and Laboratory Medicine
University of Pennsylvania
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Philadelphia, PA 19104
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