Session II - Allogeneic Cell-based Therapies

Allogeneic Cell-based Therapies

Allogeneic cell therapy products are long sought for expanding the success of cell based therapeutic approaches. Off the shelf products, manufacturable in relatively large quantities could significantly increase access for patients while reducing the cost of manufacturing for companies. The complexities of commercially manufacturing allogeneic cell products remain challenging.  Manufacturing changes are needed inevitable for the continuous process improvement.  Allogeneic cell therapy has the added challenge of the need to periodically replace the donor starting materials.  This is due to limitations in batch size based on the expansion of a single donor and hence requiring robust comparability evaluations. In this session, we will discuss the complexities of implementing a comparability strategy during manufacturing for allogeneic cell-based products. Presentations will be based on case studies in the clinical and commercial space involving healthy donor and induced pluripotent stem cells (iPSC) derived products. Panel discussions will center around phase appropriate strategies to implementing changes required to optimize manufacturing and donor replacement for allogeneic products. 

Session Speakers:

Analytical Control Strategy and Multi-Level Comparability for Genome Editing Components for Cell Therapy Products

Julien Camperi, Genentech, a Member of the Roche Group

Regulatory Strategies & Comparability Assessment For Allogenic Cell Therapy Products With Variable Donor Starting Material 

Sangeetha Prakash, Takeda Pharmaceutical Company Limited

Case Study in Comparability for an iPSC-Derived, Genome-Edited Cell Therapy Product

Jennifer Dashnau, Century Therapeutics, Inc.