Designing GMP-friendly cell and gene therapy manufacturing processesPublished: April 1, 2019
The cell and gene therapy market is exploding with medicinal products approved across multiple markets, with more products expected to receive regulatory approval in the upcoming years. Whilst all of these advancements are encouraging, a number of challenges remain in the manufacture of these transformative therapies especially as we look to move to commercial scale production.
Preparing for upscaling of cell and gene therapy products should be considered early during the product development to ensure success in the clinic and this includes streamlining manufacturing processes, sourcing raw materials, and QC for cell and gene therapy products.
Watch this On Demand webinar for the presentation featuring:
- Dr Michael Papadimitrious, Product Manager, Engineered T Cells, Miltenyi Biotec
- Dr Brian Murphy, Head of Bioprocess Development, Celgene
- Dr Xiuyan Wang, Assistant Director, Cell Therapy and Cell Engineering Facility, Memorial Sloan Kettering Cancer Center
During this on demand, you’ll have the opportunity to hear the critical points to consider when designing a manufacturing process for your clinical cell and gene therapy products, including:
- How and when to utlilize GMP materials within your product’s development.
- Understanding the impact of raw material selection on your process design and development.
- How to optimize your manufacturing process to suit your cell and gene therapy production needs
- Learnings from experienced leads in the field of cell and gene therapy
Dr Michael Papadimitrious, Product Manager for Engineered T Cells, Miltenyi Biotec GmbH
Michael is the Product Manager for Clinical Engineered T Cells at Miltenyi Biotec located in Germany. He obtained his PhD from The University of Sydney where he transfected human dendritic cells with tumor antigen IVT-mRNA and observed tumor antigen specific T cell immune responses. Prior to his PhD, he worked in Adelaide where he characterized novel monoclonal antibodies to be used for immune therapies.
Dr Xiuyan Wang, Assistant Director, Cell Therapy and Cell Engineering Facility, Memorial Sloan Kettering Cancer Center
Dr. Wang is currently Assistant Director of the Michael G. Harris Cell Therapy and Cell Engineering Core Facility at Memorial Sloan Kettering Cancer Center. Dr Wang has overseen the successful manufacturing of more than 350 clinical cell products for phase I/II clinical trials. Dr. Wang also supervises the large-scale clinical-grade retroviral production and process development. She is an active participant in the workshop of National Cell Manufacturing Consortium (GRA & Georgia Tech, NIST AMTec) and is a committee member for the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL).
Dr Brian Murphy, Director of Global Manufacturing Science and Technology, Celgene
Brian Murphy is currently Director of Global Manufacturing Science and Technology at Celgene in Warren, NJ. His group is responsible for the technology transfer, qualification, and lifecycle management of cellular therapies. Over the past decade at Celgene, Brian has worked on developing, optimizing, and scaling up cell isolation, expansion, and formulation processes for MSC, NK, and CAR-T cell products. Prior to joining Celgene, he worked in the Merck Manufacturing Division and provided engineering support for the plant start-up of the Biotechnology Manufacturing Center and for the manufacture of recombinant vaccines. With great appreciation for both scientific research and commercial practicality, Brian is currently focused on the challenge of developing novel therapeutics and processes into commercial products.
Brian holds a B.S. in Chemical Engineering from Cornell University, and a M.S./Ph.D. in Chemical and Biomolecular Engineering from the University of Pennsylvania.