Addressing the Critical Bottlenecks in the Cell & Gene Therapy Manufacturing Pathway

In by

Supported by:

GE Healthcare

Watch this exciting On Demand Webinar with a panel of leading experts from the cell and gene therapy sector as we discuss the key bottlenecks in the manufacturing pathway and the latest advances in addressing them.

This interactive Q&A session features a panel of specialists from industry and academia with questions posed by key opinion leader Dr Peter Zandstra, University of Toronto.

In this webinar they discuss:
- Challenges in managing and scaling a complex supply chain that relies on human starting material and ends with a living product.
- The critical factors to consider when deciding when and what to automate in your manufacturing pathway.
- Whether there is a need for more genuine innovation in the sector versus customizing tools and technologies from other industries.
- How to approach process changes as your product moves towards commercial-scale manufacture.

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Moderator: Prof. Peter Zandstra

Professor, University of Toronto’s Institute of Biomaterials and Biomedical EngineeringPeter Zandstra
Dr. Peter Zandstra graduated with a Bachelor of Engineering degree from McGill University in the Department of Chemical Engineering, and obtained his Ph.D. degree from the University of British Columbia in the Department of Chemical Engineering and Biotechnology, under the supervision of Jamie Piret and Connie Eaves. He continued his research training as a Post-Doctoral Fellow in the field of Bioengineering at the Massachusetts Institute of Technology (with Doug Lauffenburger) before being appointed to the University of Toronto in 1999. His vision is to translate the biological properties and potential of stem cells into useful applications that benefit society. Zandstra has focused his career on the development of, and contributions to, the field of “Stem Cell Bioengineering”, a term first used in a 2001 article by Zandstra and Nagy and which is defined as an endeavor focused on the quantitative control of stem cell fate and the development of technologies for stem cell-based therapies. “I believe that significant health and economic benefits of regenerative medicine requires the application of fundamental engineering principles to stem cell biology”, says Zandstra. An advocate for bioprocess engineering strategies and how these strategies have enabled the manufacture of many biotechnological products has significantly advanced the understanding of stem cell biology, immunology, and tissue regeneration. Most suggestively, how these biotechnology products can be translated into cellular therapies that could cure debilitating degenerative disease.

Dolores Baksh

Innovation Leader, Cell Therapy Technologies, GE HealthcareDolores Baksh
Dr Dolores Baksh is Innovation Leader for the Cell Therapy Technologies business at GE Healthcare Life Sciences and is currently on secondment at Vitruvian Networks, a company co-founded by GE Ventures and the Mayo Clinic. As VP of Business and Commercial Development, Dolores leads the business and commercial strategy to support product R&D to create a platform software solution to enable commercial availability of T-cell therapies. Prior to joining GE, Dolores was Director of R&D and Commercial Cell Manufacturing at Organogenesis Inc., where she built and led a team of talented scientists and engineers that developed the company’s product pipeline through innovation, R&D and process development. Dolores played an integral role in the development and approval of GINTUIT™ – the first allogeneic cell therapy product approved by CBER FDA. Dolores completed a Postdoctoral Fellowship at the National Institutes of Health and completed her undergraduate, masters and doctorate degrees at the University of Toronto’s Department of Chemical Engineering and Applied Chemistry and the Institute of Biomaterials and Biomedical Engineering. Dolores has been involved and held roles in a number of start-up companies – BoneTec Corp and Tissue Regeneration Therapeutics. Dolores is an active member of the Science & Technology Committee at the Alliance for Regenerative Medicine (ARM), on the Executive Team of the US Cell Manufacturing Consortium and a member of the ISCT – Commercialization Committee.

Krish Roy

Director, Marcus Center for Therapeutic Cell Characterization and Manufacturing (MC3M), Georgia Tech University
Krishendu Roy
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.

Greg Russotti

Vice President, Technical Operations, Celgene Cellular Therapeutics
Greg Russotti
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.