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GEN Protocols

Mixers

Cell Therapy: Autologous vs Allogeneic Cell Expansion

Date: April 25, 2022, 11:00 am - 12:00 pm ET

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This Mixer discusses culture systems, integrated consumables, and technical considerations for cell expansion processes in the production of autologous and allogeneic cell therapy products. Our expert panelists will discuss the implementation of scalable, cost-efficient technologies and process optimization strategies that bridge the gap between basic R&D in cell expansion technologies and GMP-ready manufacturing of commercially available cell therapies.

Cell therapies, the treatment of diseases with live cells, are now commercially available treatments where a patient’s own (autologous) or a donor’s cells (allogeneic) are collected, engineered, expanded ex vivo, and reinjected into the patient. Cell therapies are poised to revolutionize the pharmaceutical industry by providing new therapeutic options for diseases that have been considered untreatable. 

Among the complex operations required for manufacturing cell therapies, cell expansion, the most time-consuming part of the process, poses unique bioprocess challenges. This important step determines qualitative and quantitative attributes of the final cell therapy product. Cell expansion techniques face biological, regulatory, economic, logistical, safety and engineering challenges that must be addressed before cell therapies can be implemented in clinical practice. Our experts will discuss challenges and solutions in cell expansion processes, and a new technology for culturing adherent cells within hollow alginate hydrogen microfibers that ensure homogeneous and scalable 3D culture conditions and reduce development costs and production timelines. 

A live Q&A session will follow the discussion, offering you a chance to pose questions to our expert panelists. Please enter your questions in the registration form or in the Q&A box on your screen at any time during the session.

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Sebastian Rammensee, Bio-Instrumentation Project Lead & Consultant, TTP

Sebastian has a PhD in Biophysics from the Technical University of Munich, Germany. He spent his early career working on neural stem cells at UC Berkeley and now leads projects within the Life Sciences space at TTP. Sebastian has recently led programs including workflow automation for NGS sequencing and several projects for bioprocess equipment. He is currently leading the TTP team working on commercializing CellFiber’s cell encapsulation technology.

https://www.ttp.com/cell-and-gene-therapy

 

Hidetoshi Hoshiya, COO & Board Director, CellFiber Co., LTD.

Hidetoshi has a PhD in regenerative medicine from the Tottori University in Japan and over 18 years of experience in cell and gene therapy. He is currently the Chief Operating Officer and Board Director at CellFiber, a company that provides plug-and-play bio-manufacturing solutions using a proprietary cell culture technology. Before joining CellFiber, Hidetoshi developed, refined, and implemented strategies for Cell and Gene Therapy Catapult, an organization of the UK government for the industrialization of regenerative medicine. He is a fellow at the Royal Society of Medicine, the Division Chairman of Advanced Manufacturing Technology, Gene & Cell Therapy at the Manufacturing Technology Association of Biologics (MAB), a technology research association in Japan, and a Research Fellow for science and technology at the Japan Agency for Medical Research and Development (AMED).

 

Masaya Kakuta, Bioprocess Specialist at CellFiber

Masaya Kakuta has an MSc in analytical chemistry from the Tokyo University in Japan and over 20 years of experience in microfluidics and related instrument development both in academic field and in industry.