A systematic approach to implement HTST for legacy mammalian cell culture processes
May 6-11, 2018
HTST technology is being adopted for a large-scale mammalian cell culture commercial manufacturing facility for viral risk mitigation. A systematic approach has been taken to facilitate implementation of HTST for legacy programs at AstraZeneca, including risk assessment by leveraging existing experience and risk assessment decision tree as well as generating data packages as a comparability check. In this poster presentation, a risk-based approach will be discussed to allow the full implementation of large-scale HTST in GMP production. Equipment and process readiness were assessed as the two major factors independently. A series of small-scale bioreactor experiments were performed to assess the process readiness and potential impact to existing legacy processes. A lab-scale HTST unit was setup and tested as the scale-down model of the large-scale HTST unit. An initial data package was generated with multiple legacy processes and demonstrated that the use of HTST has no significant impact on the cell culture performance or product quality attributes. Additionally, the small-scale HTST unit was demonstrated to be representative of the large-scale HTST unit. Challenges through the implementation of a large-scale HTST will be discussed and lessons learned summarized.
LiYing Yang, Ramin Afrasiabi, Scott Rosenthal, Gordon Walker, and Min Zhang, "A systematic approach to implement HTST for legacy mammalian cell culture processes" in "Cell Culture Engineering XVI", A. Robinson, PhD, Tulane University R. Venkat, PhD, MedImmune E. Schaefer, ScD, J&J Janssen Eds, ECI Symposium Series, (2018). http://dc.engconfintl.org/ccexvi/39