Accelerating CAR-T process development: The power of process insight

As gene-modified cell therapies advance to address new indications, the need for rapid development of robust manufacturing processes becomes increasingly important. Process optimization sets the stage for clinical and commercial manufacturing and plays a foundational role in decreasing time to market and lowering costs of goods (COGs).

This series of case studies presents Design of Experiments (DOE)-driven development of process knowledge and rapid optimization of T-cell expansion in a miniaturized, automated multi-parallel setup as well as the phenotypic analysis of CAR-T cells with donor clustering.

• Accelerating media screening and critical process parameters (CPP) identification and optimization
• Profiling CAR-T cells and donor clustering
• Decreasing development time and COGs

Julia Hupfeld PhD

Advanced Therapies Expert, Sartorius

Julia Hupfeld has several years of experience in process development for cell-based therapeutics (ATMPs) and also worked on expansion and modulation of human mesenchymal stem cells on biomaterials in bioreactors during her Ph.D. studies at Roche. Julia holds a Ph.D. from the Technical University of Munich and an M.Sc. in Molecular Biotechnology from the University of Heidelberg and B.Sc. in Molecular Medicine from the University of Goettingen. She is a Solution Marketing Manager at Sartorius Advanced Therapies.

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SPEAKERS

Julia Hupfeld PhD

Advanced Therapies Expert, Sartorius

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