Jun
29
2021
On demand

Applying a closed, modular, semi-automated system to CAR T cell therapy manufacturing

Cell-based chimeric antigen receptor (CAR) T cell therapies have rapidly advanced in recent years, with a variety of targets in clinical research and several FDA approved products currently on the market. There has been tremendous effort to make CAR T cells more effective, safe, and persistent when treating patients. On the manufacturing side, however, errors, lot-to-lot variation, and contamination can be associated with open processes and manual handling of CAR T cells.

In this talk, we will discuss a closed cell therapy manufacturing workflow developed by Thermo Fisher Scientific. This GMP compliant, semi-automated manufacturing platform, which when used in combination with Gibco™ Cell Therapy System™ (CTS™) reagents, protocols, and analytics, can result in efficient, consistent, regulatory-compliant manufacture of CAR T cell product. Taken together with instrument modularity, digital connectivity, and cGMP compatibility, the manufacturing of therapeutic CAR T cells using this workflow will help enable a lower rate of contamination, less product failure, and higher product consistency.

Please join us to learn more about this workflow that combines the Gibco CTS Rotea Counterflow Centrifugation System with the CTS LV-MAX Lentiviral Production System, CTS Dynabeads, the HyPerforma™ Rocker Bioreactor, HyPerforma™ G3Lab™ Controller, and the CryoMed Controlled Rate Freezer for the manufacture of CAR T cells for clinical use.

Attendees will learn:

  • The various systems needed to develop and manufacture CAR T cell therapies, and solutions for mitigating the possibility of contamination, variability, and human error 
  • Benefits of implementing closed, GMP-compliant, digitally connected solutions at earlier stages in CAR T cell therapy development
  • The various available modular solutions that can assist in the implementation of a CAR T cell therapy manufacturing process

Yongchang Ji, PhD

Manager of Product Applications, Cell and Gene Therapy, Thermo Fisher Scientific

Yongchang Ji, PhD. is a process development manager in the Cell and Gene Therapy Group at Thermo Fisher Scientific in Carlsbad, CA. Yongchang currently working on development of closed, modular and semi-automatic workflow solutions for viral and non-viral cell therapy. Dr. Ji received his Ph.D. in Cell Biology and Anatomy from SUNY Upstate Medical University, NY and his undergraduate degree from Xiamen University, China.



Semsi Ensari, PhD

Senior Director, Kite Pharma

Semsi Ensari is a Senior Director at Kite Pharma leading Process Technology and Materials Development team which is responsible to develop and evaluate new technology, materials, and process automation for introduction into clinical and commercial manufacturing of cell and gene therapies. Previously, Semsi built and led a team of Southern California MSAT leads in support of clinical and commercial manufacturing of cell therapy and viral vector manufacturing operations. Prior joining Kite, Semsi held positions with increasing responsibilities in Research, Process Development and Manufacturing at Schering-Plough, Ambrx, and Genentech. Over the course of 20 years of service, Semsi has a proven track record in successfully developing, implementing and maintaining processes for clinical and commercial production of cell and gene therapies, therapeutic proteins, and antibodies. Semsi holds a Bachelor of Science in Chemical Engineering from Bogazici University in Turkey, Master’s and PhD in Biochemical Engineering from University of California, Irvine.

Nathan Moore, PhD

Nathan Moore, PhDAssociate Director, Engineering & Automation Cell Therapies, Pharmaceutical Sciences, Takeda

Dr Nathan Moore is an Associate Director in Cell Therapies, Automation and Engineering at Takeda Pharmaceuticals. He has managed multiple projects to build novel tools and systems with third party engineering firms and co-ordinatedand directed development and evaluation of novel cell therapy manufacturing technologies across Takeda’s global process development and manufacturing teams. Nathan is a PhD cancer biologist with experience in molecular biology, microfluidics and engineering of cell bioprocessing tools. He enjoys sitting at a nexus between biology and engineering, working to develop novel tools to automate and improve cell therapy manufacturing and decrease the overall cost and time to patients.

SPEAKERS

Yongchang Ji
Manager of Product Applications, Cell and Gene Therapy, Thermo Fisher Scientific
Yongchang Ji
Manager of Product Applications, Cell and Gene Therapy, Thermo Fisher Scientific
Semsi Ensari, PhD
Senior Director, Kite Pharma
Semsi Ensari, PhD
Senior Director, Kite Pharma
Semsi Ensari is a Senior Director at Kite Pharma leading Process Technology and Materials Development team which is responsible to develop and evaluate new technology, materials, and process automation for introduction into clinical and commercial manufacturing of cell and gene therapies. Previously, Semsi built and led a team of Southern California MSAT leads in support of clinical and commercial manufacturing of cell therapy and viral vector manufacturing operations. Prior joining Kite, Semsi held positions with increasing responsibilities in Research, Process Development and Manufacturing at Schering-Plough, Ambrx, and Genentech. Over the course of 20 years of service, Semsi has a proven track record in successfully developing, implementing and maintaining processes for clinical and commercial production of cell and gene therapies, therapeutic proteins, and antibodies. Semsi holds a Bachelor of Science in Chemical Engineering from Bogazici University in Turkey, Master’s and PhD in Biochemical Engineering from University of California, Irvine.
Nathan Moore, PhD
Associate Director, Engineering & Automation Cell Therapies, Pharmaceutical Sciences, Takeda
Nathan Moore, PhD
Associate Director, Engineering & Automation Cell Therapies, Pharmaceutical Sciences, Takeda
Dr Nathan Moore is an Associate Director in Cell Therapies, Automation and Engineering at Takeda Pharmaceuticals. He has managed multiple projects to build novel tools and systems with third party engineering firms and co-ordinatedand directed development and evaluation of novel cell therapy manufacturing technologies across Takeda’s global process development and manufacturing teams. Nathan is a PhD cancer biologist with experience in molecular biology, microfluidics and engineering of cell bioprocessing tools. He enjoys sitting at a nexus between biology and engineering, working to develop novel tools to automate and improve cell therapy manufacturing and decrease the overall cost and time to patients.