Let’s talk integrationPublished: December 9, 2019
The complexities of integrating processes and scaling-up the manufacturing of cell and gene therapies is a topic that is prevalent in our maturing industry. Vendors and producers are focusing heavilyon developing purpose-built solutions, integrating as many steps as possible, sometimes leveraging entirely new technologies rather than legacy approaches from the blood processing and biologics sector. This can present new challenges as the implementation often impacts process development, automation and regulatory teams within an organization.
This webinar provide a short example of the ekko™ system processing cell aggregates while integrated with a bioreactor. A cross-functional panel discuss integration challenges and learnings related to an integration strategy.
- A comprehensive view of key considerations when implementing integrated solutions from the perspective of process development, automation and regulatory
- First-hand examples of implementing automation strategies and technologies
- When, where and how to consider implementing such technologies and the balance of risk / benefit
Nina Bauer, VP Business Development, FloDesign Sonics Inc
Nina Bauer, a key figure in the cell and gene therapy community joined FloDesign Sonics in September as VP of Business Development. She leads the commercial aspects of establishing, launching, and further adoption of this disruptive technology. Previously Nina led Lonza’s Autologous Cell Therapy business, with manufacturing sites in the US and Europe. As part of this role, she was also in charge of establishing novel manufacturing technologies, most notably the Octane Cocoon™ platform. Prior to joining Lonza, Nina held business development roles at the Cell Therapy Catapult (London), and the University of Edinburgh, and worked as Life Science Consultant for regenerative medicine businesses.
Mark Dudley, PhD, SVP, Product Development, Adaptimmune
Dr. Mark Dudley is a Senior Vice President at Adaptimmune Therapeutics, a leader in genetically modified T cell therapies for solid cancers, where he is responsible for manufacturing and development. Dr. Dudley has been a pioneer in the field of immunotherapy manufacturing, and has developed and implemented innovative early process design with accompanying analytics for multiple therapies. Previously, as Director of New Cell Products in the Cell and Gene Therapies division of Novartis Pharmaceutical Corp, Dr Dudley was responsible for establishing scalable, GMP-compliant production strategies and facilitating globalization of CAR-T products and platforms. As Director of the Cell Manufacturing Facility at the Surgery Branch of the National Cancer Institute, NIH, in Bethesda, MD, Dr Dudley investigated tumor rejection antigens, T cell specificity and function, and methods for the generation and administration to patients of T cell therapies. His work has resulted in more than 100 peer-reviewed publications, and he is co-author on numerous seminal papers including early tumor-infiltrating lymphocytes studies demonstrating that adoptive T-cell transfer has tumor eradicating potential. Dr. Dudley earned a Ph.D. in Biological Sciences at Stanford University, and had post-doctoral fellowships at The University of Pennsylvania in Philadelphia, PA and at the Jackson Laboratory in Bar Harbor, ME.
Dr Christiane Niederlaender, Director, AMBR Consulting Ltd
Christiane has spent 12+ years in medicines, tissue, cell and gene therapy regulation. For the last 8 years she has worked at the MHRA, the UK’s medicine regulator, where she has assessed all classes of biological medicines at both UK and EU level and acted as the UK representative at the European Medicines Agency’s (EMA) committee for advanced therapies (CAT). Christiane was the Rapporteur or Co-Rapporteur for several advanced therapy medicinal products (ATMPs) and many other biological product applications. She acted as the Rapporteur for the EMA Gene Therapy Guideline and was a drafting group member for other CAT guidelines. As acting Manager for the Biologicals Unit, Christiane was actively involved in the MHRA’s Brexit preparations and has in-depth knowledge of the MHRA no-deal provisions.
Prior to joining the MHRA, Christiane worked for the UK competent authority responsible for the European Tissues and Cells Directive.
Christiane received a Ph.D. in molecular developmental neurobiology from Kings College London and has spent several years researching and publishing in the area of cancer, embryonic development and neurobiology. Before joining the public sector, Christiane has also taken a law degree.
Christiane has recently left the public sector to become an independent regulatory consultant.
Jon Ellis, Manager – Cell Therapy, Invetech
Jon Ellis is the San Diego Cell Therapy Manager at Invetech, an engineering and consultancy firm focused on the development of platforms and systems for commercial-scale GMP manufacturing. Prior to joining Invetech in 2018, Jon had 15 years’ experience in the cell therapy industry, initially in GMP manufacturing management and process implementation and, more recently, in development of novel cell isolation and selection technologies.