Advances in CAR-T manufacture – Bridging the commercialization gaps

Against the backdrop of continued promising clinical data and approvals for an increasing range of indications, CAR-T cell therapies look set to become an integral part of modern healthcare. As the field continues to develop, it’s an opportune time to reflect on the progress thus far and, more importantly, look at the key lessons we have learnt from the early challenges faced.

This webinar provides insight into:

• The critical gaps in our knowledge and understanding of the CAR-T manufacturing pathway that need to be addressed to support commercial and clinical success;
• Manufacturing strategies for the successful commercialization of CAR-T therapies including closed, automated, single-use manufacturing platforms; all-in-one solutions versus multiple unit operations;
• Process development strategies: challenges and approaches for CAR-T process characterization and validation;
• The latest advances in the bioanalytical toolkit and the optimal analytic strategy for your product;
• Quality by Design approach for the development and optimization of CAR-T manufacturing including CoGS evaluation as a tool for process design and planning; and strategies for reducing COGS and maximizing throughput.

Hear from three leading experts:

• Ian Johnston, Industrial and Academic Cooperations Manager, Senior Project Manager, Miltenyi Biotec
• Krish Roy, Director, Marcus Center for Therapeutic Cell Characterization and Manufacturing (MC3M), Georgia Tech
• Greg Russotti, Vice President, Technical Operations, Celgene Cellular Therapeutics

Ian Johnston

Senior Project Manager, R&D at

Dr. Johnston is responsible for the development of cutting edge technologies to enable cell and gene therapies to be applied routinely in the clinic. Since joining Miltenyi Biotec in 1999, Dr. Johnston has developed a number of reagents and procedures to improve the efficiency of genetic modification of primary cells such as human T and stem cells. A number of these procedures have been fully automated on a functionally closed cell processing platform – the CliniMACS® Prodigy. In addition, Dr. Johnston has lead development of numerous products for magnetic isolation of cells, molecules, organelles and for use in the field of HIV research. He has been Principle Investigator on a number of European consortium grants focused on the genetic modification of stem cells, most recently Cell-PID and SCIDNET. His group is also investigating new targets for Chimeric Antigen Receptors (CAR) to be used in T cell cancer immunotherapies.

Prior to joining Miltenyi, he studied Natural Sciences at Cambridge University where he also completed a PhD studying immunopathological mechanisms in the CNS. This was followed by postdoctoral research at Würzburg University with Prof. Volker ter Meulen working with recombinantmeasles virus systems, supported by two fellowships from the Wellcome Trust and Alexander von Humboldt Foundation.

Krishnendu Roy

Professor, Director, Marcus Center for Therapeutic Cell Characterization & Manufacturing (MC3M) at Georgia Institute of Technology

Dr. Roy’s research interests are in the areas of scalable cell manufacturing, immunoengineering, stem-cell engineering, and controlled drug and vaccine delivery technologies, with a particular focus in biomaterials. In recognition of his seminal contributions to these fields, Dr. Roy has been elected Fellow of the American Institute for Medical and Biological Engineering (AIMBE) and Fellow of the Biomedical Engineering Society (BMES). In addition, Dr. Roy has received numerous awards and honors, including Young Investigator Awards from both the Controlled Release Society (CRS) and the Society for Biomaterials (SFB), the NSF CAREER award, and the Global Indus Technovator Award from MIT, among others.

He serves on the editorial boards of the Journal of Controlled Release, the European Journal of Pharmaceutics and Biopharmaceutics, the Journal of Immunology and Regenerative Medicine, and AIChE Journal of Advanced Manufacturing and Processing. He is also a member of the Forum on Regenerative Medicine of the National Academies of Science, Engineering and Medicine (NASEM) and a board member of the newly established Standards Coordinating Body (SCB) for Cell and Regenerative Therapies.

Greg Russotti

Vice President, Technical Operations at Celgene Corporation

In his current position at Celgene Cellular Therapeutics, Dr. Russotti is responsible for process development, analytical method development, clinical manufacturing, quality control and quality operations. Prior to joining Celgene in 2006, Russotti spent nearly 15 years at Merck Research Laboratories developing products that included live virus vaccines, monoclonal antibodies, recombinant vaccines and microbially-produced natural products. He worked on development, scale-up and tech transfer of cell culture, microbial fermentation and downstream isolation processes to clinical and commercial manufacturing facilities. Russotti received his B.S. and M.S. degrees in Chemical Engineering from Rensselaer Polytechnic Institute and his PhD in Chemical and Biochemical Engineering from Rutgers University.