Aby J Mathew
BioLife Solutions Inc., USA
Title: Biopreservation considerations for GMP cell and tissue bioprocessing, clinical development, and delivery
Biography: Aby J Mathew
Cellular therapies, regenerative medicine, and biobanking utilize cell and tissue products sourced from blood, bone marrow, and various tissues. Th e clinical and commercial utility of these products is potentially impacted by stability limitations, which include transport of the source material and biopreservation of the fi nal cell or tissue product (either frozen or non-frozen). Oft en in cell and tissue processing, there may exist a gap between biopreservation method optimization from a cryobiology perspective and the process development that results in the cryopreserved or non-frozen cell/tissue product. Traditional home-brew reagent cocktails (including serum) utilized for biopreservation are a point of risk within a GMP clinical manufacturing process and may be suboptimal options in comparison to pre-formulated GMP intracellular-like formulations. Th is discussion will off er best practices recommendations for integrating biopreservation methods within Good Manufacturing Practices (GMP), share lessons learned from cell therapy manufacturing and biobanking, and off er suggestions for integration of biopreservation methods within biobanking and regenerative medicine with consideration to the quality and regulatory footprint. Topics include best practices in optimizing biopreservation workfl ow, including transportation and storage of source material and fi nal dose, post-preservation assessment variability, and evaluation, selection, and validation of ancillary and excipient reagents.