The digital revolution: Technological innovations to enable automation in cell therapy manufacturing

Thursday 12:06 PST / 15:06 EST / 20:06 GMT / 21:06 CET

Sponsor

The digital revolution: Technological innovations to enable automation in cell therapy manufacturing

Cell therapy manufacturing workflows typically involve multiple complex steps, requiring extensive hands-on and labor-intensive interventions. They also typically involve several open processes, spanning a multitude of different products. As emerging therapeutics move through the clinical pipeline, scale and regulatory compliance have come to the forefront of the discussion. Closed, modular systems can help overcome some of the current cell therapy manufacturing challenges associated with lack of flexibility, maintenance of sterility, and a lack of standardization. A key to addressing these challenges and facilitate scalability lies in both process automation and digital automation.

In this webinar, we will discuss how a fully automated cell therapy manufacturing process, that addresses digital connectivity and instrument-to-instrument compatibility, can increase quality of the final product, and reduce manufacturing failure rates.

Considerations and benefits of a closed, modular cell therapy workflow
The time and cost-saving advantages of implementing a fully automated manufacturing workflow that is regulatory compliant
The importance of digital connectivity solutions to ensure process and data integrity and integration of instruments into your DCS system
The importance of technology as it relates to automation and standardization within cell therapy manufacturing”

Sean Chang

Manager, Early Innovation, Cell and Gene Therapy, Thermo Fisher Scientific

Dr. Sean Chang, Ph.D. is an R&D Team Leader in the Cell and Gene Therapy business unit at Thermo Fisher Scientific and is working on the integration and automation of cell therapy manufacturing workflow. Prior to this role, he was a Process Development Scientist, leading manufacturing process optimization of an allogeneic CAR-T product. Sean also gained extensive experiences in new product development in his previous career role as an R&D Scientist, where he identified novel T cell genome editing and non-viral delivery solutions, and worked on new closed modular instruments. Sean received his Ph.D. in Integrative Molecular and Biomedical Sciences from Baylor College of Medicine, where he focused on the mechanisms underlying therapeutic resistance of breast cancer.

Bruce Greenwald

DeltaV Platform Business Development Manager Emerson Automation Solutions

Bruce Greenwald is the DeltaV Platform Business Development Manager for Emerson Automation Solutions, located in Austin, TX. In his current role, Mr. Greenwald assists customers in understanding the features and benefits of DeltaV to improve their automation experience. Mr. Greenwald is a 1979 graduate of the University of Kansas with a degree in Chemical Engineering. He started his career with the Dow Chemical in Freeport, TX and joined Fisher Controls in 1983 as a systems engineer. Mr. Greenwald joined the RE Mason Company, an Emerson Impact Partner, in 2000, executing PROVOX and DeltaV projects. He held several positions at RE Mason, and in 2011, rejoined Emerson. His 4 decade-long career has been focused on process control.

Krishnendu Roy

Director, NSF Engineering Research Centre for Cell Manufacturing Technologies (CMaT); Director, Marcus Center for Therapeutic Cell Characterization and Manufacturing (MC3M), Georgia Tech and Emory University

Dr. Krishnendu (Krish) Roy received his undergraduate degree from the Indian Institute of Technology (Kharagpur, India) followed by his MS from Boston University and his PhD in Biomedical Engineering from Johns Hopkins University. After working for 2 years at Zycos Inc., a start-up biotechnology company, Dr. Roy left his industrial position to join the Biomedical Engineering Faculty at 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 now the Robert A. Milton Chaired Professor in Biomedical Engineering. At Georgia Tech, he also serves as the Director of the newly established NSF Engineering Research Center (ERC) for Cell Manufacturing Technologies (CMaT) and The Marcus Center for Therapeutic Cell Characterization and Manufacturing (MC3M) – as well as the Director of the Center for ImmunoEngineering. He is also the Technical Lead of the NIST/AMTech National Cell Manufacturing Consortium (NCMC), 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 scalable cell manufacturing, Immuno-engineering, stem-cell engineering and controlled drug and vaccine delivery technologies, with particular focus in biomedical materials. 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), NSF CAREER award, Global Indus Technovator Award from MIT, the CRS Cygnus Award etc. He is also the recipient of Best Teacher Award given by the Biomedical Engineering Students at UT-Austin and the best advisor award given by bioengineering students at Georgia Tech. He serves as a member of the Editorial Boards of the Journal of Controlled Release, the European Journal of Pharmaceutics and Biopharmaceutics, and the Journal of Immunology and Regenerative Medicine. He is 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.