Achieving consistency in fill and finish for cell therapies

Wednesday 08:00 PST / 11:00 EST / 16:00 GMT / 17:00 CET

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Achieving consistency in fill and finish for cell therapies

The fill and finish process for cell therapies is not as straightforward as it may seem. This final step represents the total sum of days to weeks of manufacturing time and thus carries the highest failure costs.

Further, despite many cell therapies requiring a single batch for a single patient, multiple bags are required for multiple dosing strategies, QC release, or reserve doses. Different storing and shipping requirements for each bag condition can also complicate the overall process – especially when DMSO is involved in cryopreservation.

In this webinar, we detail how automation can achieve consistency across these final product bags in a closed environment, reducing hands-on time and risk to the therapy's integrity.

The common bag requirements for cell therapies
Scale-out strategies for multiple bag requirements
How automation can bring bag-to-bag volume consistency within 4%
Efficiency in filling as a function of viable cell number
Post-thaw viabilities after fill and finish

Min Sung Park

Process Development Scientist at Charles River Laboratories

Min Sung Park is a process development scientist at Charles River Laboratories. He has a strong background in tissue engineering and regenerative medicine. His projects have included MSCs, primary immune cells, and various mammalian cells. He obtained his PhD from the school of medicine at Yonsei University in South Korea, where he studied developmental biology, stem cell biology, and tissue engineering for skeletal tissue regeneration in department of orthopedic surgery. As a postdoc fellow, he studied stem cell therapy for treatment of several diseases including cancer, and adipose tissue metabolism. After his postdoc fellowship, he worked in both clinical and industry settings, prior to joining CRL for novel biologics R&D such as cells-, gene- and tissue-based therapeutics products for cancer, autoimmune diseases, and sport medicine/orthopedic indications.

Meredith Safford

Process Development Scientist at Charles River Laboratories

Meredith works at Charles River’s Hanover, MD site, a contract manufacturing and development organization (CDMO) that focuses on cell and gene therapies. Her projects have included mesenchymal stem cells, cancer cell lines, and primary immune cells.

Meredith has a PhD in Biology from Johns Hopkins University and an MS in Healthcare Management from Johns Hopkins Carey Business School. Her post-doctoral fellowship research projects at Johns Hopkins School of Medicine and at the National Institute on Aging focused on T cell activation and anergy induction. Before joining Johns Hopkins as a faculty member, Meredith gained scientific publication experience working on the editorial staff of the Journal of Immunology.