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Advancing Manufacturing Faster for Next Generation hiPSC-Based Clinical Therapies

January 27th, 2022 | Time: 16:00 CET
Virtual Workshop (BioWin-Catalent)

 

Human induced pluripotent stem cell (hiPSC)-based therapy is currently at the forefront of technology boom and is advancing at a rapid pace. Generating hiPSCs under current Good Manufacturing Practice (cGMP) conditions, tissue sourcing, testing, and scale of production, are now considered as critical components of both clinical and commercial successes. In this webinar, the presenters will share their experiences of the development and manufacturing of hiPSCs.

The expert panel will highlight key considerations for driving clinical and commercial success with hiPSCs as starting materials, including aspects such as their derivation, expansion, and differentiation. The experts will also share strategies that can improve the speed, quality, cost of goods, differentiation, and scaling up of hiPSC-based therapies.

Key learning objectives:

1. Learn what key criteria a cell therapy developer should use in selecting starting material for hiPSC generation
2. Understand the process development and characterization of hiPSC- derived cell therapies and how to address manufacturing challenges
3. Insights into expansion and differentiation of hiPSC in large-scale production.

AGENDA

5 min Welcome & Introduction

 

 

 

15 min Achieving Clinical Quality by Source and Design for a Universal Platform of hiPSC-based Therapies
– Special consideration of starting material selection for hiPSC generation to meet quality standard requirements
– Key issues in addressing immune compatibility of hiPSC
– Rationale for immune matched human leukocyte antigen (HLA)-homozygous iPSCs for ‘off-the-shelf’ clinical therapies

15 min Best Practices of hiPSC-derived Cell Therapy Manufacturing
– Addressing the challenges of manufacturing hiPSC-derived cell therapy products under cGMP
– What are the main process development and characterization considerations?
– Key drivers to accelerate an hiPSC-based therapy’s path to clinic

15 min Scalable Closed System Manufacturing of hiPSC-Derived Cell Types for Cell Therapies
– Key considerations in cultivation and differentiation strategies of hiPSCs, and their bioprocessing challenges
– Advanced techniques for scaling up hiPSCs in stirred-tank bioreactors
– Application of in silico process modeling during large scale production

10 min Q&A and Closing

SPEAKERS

Martin DeBrauwere
Director, Business Development,
Catalent Cell & Gene Therapy, Gosselies, Belgium

Thierry Ferain
Director Innovation & Growth
BioWin, Gosselies, Belgium

Boris Greber, Ph.D.
Head of R&D, iPSC
Catalent Cell & Gene Therapy, Dusseldorf, Germany

 

 

 

 

James Crutchley, Ph.D.
Senior Process and Analytical Development Manager
Catalent Cell & Gene Therapy, Gosselies, Belgium

 

 

 

Robert Zweigerdt, Ph.D.
Principal Investigator
Leibniz Research Laboratories for Biotechnology and Artificial Organs (LEBAO), Hannover Medical School (MHH), Germany

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