Terumo BCT: Downstream Processing Challenges in Cell Therapy Manufacturing

Terumo BCT: Downstream Processing Challenges in Cell Therapy Manufacturing

04/02/2019, 2:15 PM - 3:00 PM

Javits Conventions Center - INNOPHEX Stage - Booth 3941
With the recent FDA approval of the CAR-T cell therapies Kymriah® from Novartis and Yescarta® from Kite Pharma there has been a renewed interest in bioprocessing and the manufacturing facilities required to meet the commercial demands for these novel cell therapy products. Much of the industry focus has been on the upstream process with particular emphasis on large scale cell expansion. In fact, optimization of bioreactor yields often results in downstream process bottlenecks. The challenges of cell therapy process development that arise after the cell expansion stage can include: harvesting, washing, cell purification, cell concentration, formulation, fill and finish, and preservation depending upon the therapy. A successful commercial production process must be scalable, robust, reproducible and results in a therapy that is affordable and economical. Compounding the difficulty, many current cell separation technologies are not compatible with large scale processes. Additionally, since the product is the process, manufacturing processes must maintain the functionality and the critical quality attributes of the cellular material throughout. After an overview of the cell therapy manufacturing upstream process an examination of the downstream process challenges will be presented. The strengths and weaknesses of current approaches will be examined. Where possible, automated solutions will be highlighted. And finally, we will highlight an option available in the area of final formulation, fill & finish area: the Finia Fill and Finish System from TerumoBCT.


  • Jim Beltzer


    Sr. Manager Global Strategic Medical Affairs – Cell Therapy Technologies,

    Terumo BCT

    Jim recently transitioned to the Global Strategic Medical Affairs team to better leverage both his technical background and his commercial exposure...

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