Downstream Processing Challenges in Cell Therapy Manufacturing

Sponsored by: TERUMO BCT

Speakers

Jim Beltzer, MS, PhD

Sr. Manager, Global Strategic Medical Affairs, Cell Therapy Technologies - Terumo BCT
BIOGRAPHY
Geoffrey Uhl, MBA, BS

Sr. Engineering Manager, Cell Processing - Terumo BCT
BIOGRAPHY

Abstract

DATE: April 11, 2019

TIME: 10:00 AM PDT

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 and reproducible and must result in a therapy that is affordable. Compounding the difficulty, many current cell separation technologies are not compatible with large-scale processes. Since the product is the process, manufacturing processes must maintain the functionality and the critical quality attributes of the cellular material throughout.

Who may be interested:

Clinicians, researchers, lab technologists and cell therapy industry professionals
Cell and gene therapy manufacturing professionals
Contract development and manufacturing organizations (CDMOs) and contract manufacturing organizations (CMOs)

Learning objectives:

Gain a greater understanding of the downstream part of the cell processing and its challenges
Understand the strengths and weaknesses of current approaches
Discover a new option in the area of final formulation, fill and finish—the Finia^®Fill and Finish System from Terumo BCT

LabRoots is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E. ® Program. By attending this webinar, you can earn 1 Continuing Education credit once you have viewed the webinar in its entirety.