Cellular therapies and regenerative medicine utilize cell and tissue products sourced from blood, bone marrow, and various tissues. The clinical and commercial success of these products is potentially impacted by stability limitations, which include transport of the source material and biopreservation of the final cell or tissue product (either frozen or non-frozen). Traditional isotonic/extracellular-like home-brew reagent cocktails (including serum) utilized for biopreservation are an area of risk within a GMP (Good Manufacturing Practices) clinical manufacturing process. This discussion will address points of Quality/Regulatory concern for qualification of biopreservation reagents within GMP systems. Topics include transportation and storage of source material and final dose, intermediate manufacturing process hold steps, and evaluation, selection, and qualification of ancillary and excipient reagents. A case study sharing the development of GMP cryopreservation media into clinical applications will be discussed.Source of funding: None declared.Conflict of interest: None declared.amathew@biolifesolutions.com