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, Industrial and Academic Cooperations Manager, Senior Project Manager, Miltenyi Biotec, Germany
Dr. Ian 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, he has developed a number of reagents and fully automated procedures to improve genetic modification of primary cells such as human T and stem cells, also in the framework of EU consortium projects such as Cell-PID and SCIDNET. His group is also investigating new technologies to be used in CAR T cell cancer immunotherapies. He studied Natural Sciences at Cambridge University UK, also completing his PhD in immunology and virology, before a period of postdoctoral research in Würzburg, Germany.
Krish Roy, Director, Marcus Center for Therapeutic Cell Characterization and Manufacturing (MC3M), Georgia Tech, USA
Dr. Krishnendu (Krish) Roy received his undergraduate degree from the Indian Institute of Technology (India) followed by his MS from Boston University and his PhD in Biomedical Engineering from Johns Hopkins University. Following his PhD, he joined Zycos Inc., a start-up biotechnology company where he served first as a Scientist and then as a Senior Scientist in the Drug Delivery Research group. Dr. Roy left his industrial position to join The University of Texas at Austin in 2002, where he was most recently Professor and Fellow of the Cockrell Chair in Engineering Excellence. He left UT-Austin in July of 2013 to move to Georgia Tech. where he is currently the Carol Ann and David D. Flanagan Professor and Wallace H. Coulter Distinguished Faculty Fellow. At Georgia Tech, he also serves as Director of the Center for ImmunoEngineering, a consortium of 30+ faculty focused on using engineering tools and methodologies to understand and modulate the immune system in health and disease. He is also currently the Technical Lead of the Cell Manufacturing Consortium, a national public-private partnership, focused on addressing the challenges and solutions for large scale manufacturing of therapeutic cells. Dr. Roy’s research interests are in the areas of controlled drug and vaccine delivery technologies, Immuno-engineering, stem-cell engineering and cell manufacturing, with particular focus in biomedical materials in cancer and immunotherapies. In recognition of his seminal contribution 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 Young Scientist Award from HSEMB, NSF CAREER award, Global Indus Technovator Award from MIT, the CRS Cygnus Award etc. He has also received the translational research award from the Coulter foundation and the bioengineering grant from the Whitaker Foundation.
Greg Russotti, Vice President, Technical Operations, Celgene Cellular Therapeutics
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 Ph.D. in Chemical and Biochemical Engineering from Rutgers University.