Expert Roundtable: overcoming raw material challenges in cell & gene therapy manufacturingPublished: May 18, 2020
Raw and starting materials: troubleshooting supply, management and optimization issues
David Digiusto, Bernd Leistler & Tom Walls
Chief Technical Officer, Semma Therapeutics David has over 28 years of experience in the scientific, clinical and regulatory aspects of cells as therapeutic agents including the isolation, characterization and genetic modification of hematopoietic stem cells and T-cells for clinical applications. He has been instrumental in the creation of six GMP compliant biologics manufacturing facilities and associated quality systems, production and QC testing programs. Under his direction, plasmid DNA, CAR-T-cells, regulatory T-cells, engineered stem cell grafts and gene modified hematopoietic stem cell products have been manufactured and released for use in Phase I/II clinical trials.
Vice President Production, CellGenix Bernd has a long track record as protein specialist. He joined CellGenix in 2003, and is currently responsible for all GMP and preclinical cytokine products for further manufacturing use, as well as process development for protein production which includes new packaging formats. Following his degree in chemistry he completed his dissertation on the structure, function, folding and assembly of oligomeric proteins. His professional career started at a leading manufacturer of diagnostic autoantibody immunoassays, where he managed the Biotechnology Department and developed it as a corporate service unit for recombinant and conventional human autoantigens and allergens.
Associate Director of Supply Chain, Bluebird Bio Tom Walls has over 15 years of supply chain experience in life sciences. He has led initiatives in business process management, production capacity management, global trade compliance and global planning. He has experience in cell & gene therapies, as well as small molecules, branded, generics, commercial and pre-clinical stage companies.