Addressing the critical bottlenecks in the cell & gene therapy manufacturing pathway
Jun
21
2017
On demand

Addressing the critical bottlenecks in the cell & gene therapy manufacturing pathway

Wednesday 08:15 PDT / 11:15 EDT / 16:15 BST / 17:15 CEST
Sponsor
Addressing the critical bottlenecks in the cell & gene therapy manufacturing pathway

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.

By registering to view this On Demand Webinar you are also signing up as a member of Cell & Gene Therapy Insights and agree to be contacted by Cell & Gene Therapy Insights’ sponsors. We will email you a username and password so you can read all our open access content.

Peter Zandstra
Peter Zandstra
Professor & Director, School of Biomedical Engineering at University of British Columbia

Peter Zandstra graduated with a Bachelor of Engineering degree from McGill University in the Depart-ment of Chemical Engineering, obtained his Ph.D. degree from the University of British Columbia in the Department of Chemical Engineering and Biotechnology and continued his research training as a Post-Doctoral Fellow in the field of Bioengineering at MIT.  In 1999, Dr Zandstra began his faculty ap-pointment at the University of Toronto’s Institute of Biomaterial and in 2016 was appointed University Professor, the university’s highest academic rank.  In July 2017, Zandstra joined the University of Brit-ish Columbia as the Founding Director the School of Biomedical Engineering and as the Director of the Michael Smith Laboratories. In these roles, he aims to build programs with deeper interactions be-tween the Faculties of Applied Science, Science and Medicine, especially as related to innovative re-search and training programs.

Peter is the Canada Research Chair in Stem Cell Bioengineering and is a recipient of a number of awards and fellowships including the Premiers Research Excellence Award (2002), the E.W.R. Steacie Memorial Fellowship (2006), the John Simon Guggenheim Memorial Foundation Fellowship (2007), and the Uni-versity of Toronto’s McLean Award (2009). Dr. Zandstra is a fellow of the American Institute for Medical and Biological Engineering and the American Association for the Advancement of Science. Peter’s re-search focuses on understanding how complex communication networks between stem cells and their progeny influence self-renewal and differentiation, and how this information can be applied to the de-sign of novel culture technologies capable of controlling cell fate.

Dolores Baksh
Dolores Baksh
Innovation Leader, Cell Therapy Technologies at Cytiva
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.
Krishnendu Roy
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
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.

SPEAKERS

Peter Zandstra
Peter Zandstra
Professor & Director, School of Biomedical Engineering at University of British Columbia
Dolores Baksh
Dolores Baksh
Innovation Leader, Cell Therapy Technologies at Cytiva
Krishnendu Roy
Krishnendu Roy
Professor, Director, Marcus Center for Therapeutic Cell Characterization & Manufacturing (MC3M) at Georgia Institute of Technology
Greg Russotti
Greg Russotti
Vice President, Technical Operations at Celgene Corporation

You might also like

Case study: becoming the first GMP-certified cell and gene therapy manufacturing facility in Thailand

Case study: becoming the first GMP-certified cell and gene therapy manufacturing facility in Thailand

Kitipong Uaesoontrachoon
28 November 2023
Watch
From concept to clinic: overcoming the challenges of potency assays in cell and gene therapy development

From concept to clinic: overcoming the challenges of potency assays in cell and gene therapy development

Audrey Chang, Joe Newcome
10 December
in 14
Days
Register
Can primary packaging selection help mitigate particulate risks in cell and gene therapy manufacturing?

Can primary packaging selection help mitigate particulate risks in cell and gene therapy manufacturing?

S Werner, S Curbishley, J Jendusa
10 April
Watch
Improving cell therapy manufacturing with on-line monitoring of critical process parameters during cell expansion

Improving cell therapy manufacturing with on-line monitoring of critical process parameters during cell expansion

Boris Aleynik, Mindy Miller
16 July
Watch
Trends in innovation for downstream process intensification, product yield, single-use closed systems, and gentle ATMP bioprocessing: a KOL panel discussing 2024 insights in gene therapy manufacturing

Trends in innovation for downstream process intensification, product yield, single-use closed systems, and gentle ATMP bioprocessing: a KOL panel discussing 2024 insights in gene therapy manufacturing

Rachel Legmann, Andrew Tustian
27 February
Watch