Liaison(s): James Giulianotti, Anson Lee
Successful cryopreservation of the recombinant cell source used in the bio-manufacturing of these biologics is critical to ensure sufficient material is produced to meet patient demands. Therefore, a well-defined and robust process for the cryopreservation or “Cell Banking” of recombinant cells Master Cell Bank (MCB) or Working Cell Bank (WCB) is a desire of any biologic manufacture. Cell banking involves freezing cells in a solution with cryopreservation agents and then stored in very low freezing temperatures, such as -80°C or liquid nitrogen. Conditions prior to freezing and during the freezing process can result in negative effects, such as intracellular ice formation or cellular dehydration, which can result in variable and unpredictable post thaw cell bank performance in the manufacturing facility. By characterizing parameters associated with the Cell Banking process (e.g., hold times, temperature and cryoprotectant concentrations) a more robust process to generate cell banks for biologic manufacturing can be developed.
The KGI TMP was tasked to evaluate and assess undefined parameters of cell banking and characterized the potential impact from the various freezing conditions by performing shake flask experiments from glass ampoules and vials; then the TMP performed data analysis using DOE and JMP to provide findings and recommendations from summarizing the findings.