MAR 30, 2021 8:00 AM PDT

Utilizing the Gibco™ CTS™ Rotea™ System, a versatile closed manufacturing system, for cell and gene therapy development

  • Cell and Gene Therapy Senior Business Development Manager

      Mary Ann Santos is a Cell and Gene Therapy Senior Business Development Manager for Thermo Fisher Scientific. She holds a Bachelor’s Degree in Biochemistry and Biology from the University of San Francisco. Mary Ann has over 22 years of experience in the biotechnology industry with expertise in Cell Biology and Life Sciences. This includes working with biotechnology, bioindustrial and biopharmaceutical companies in addition to academic institutions across the western region of North America. She has also led research project teams with a focus in next generation cancer therapeutics.

    • Process Development Engineer II, ViaCyte

        Emily Benz is an Engineer/Scientist in ViaCyte’s Process Development department, holding a Masters in Regenerative Medicine from Cal Poly San Luis Obispo. She has been working at ViaCyte for over three years, initially performing research on cell product development in the R&D setting and later transitioning to the PD team. She is currently heading the scale-up effort for stem cell differentiation, involving production of pancreatic endoderm cells (PEC-01TM) in 3L and 15L bioreactors and the development of a closed process for scalable product manufacture.

      • Biomedical Engineering Master's student at Cal Poly San Luis Obispo

          Eric Dubofsky is a Biomedical Engineering Master's student at Cal Poly San Luis Obispo, currently interning at ViaCyte's Process Development department under Emily Benz and Alan Agulnick. His internship involves designing and executing experiments to optimize the Rotea for processing stem cell-derived aggregates during bioreactor culture. Eric is also involved with integrating the Rotea into the current aggregate culturing process and supporting scale-up efforts in other areas. Ultimately, this work will help improve process efficiency and support ViaCyte’s ambitious scale-up goals. 


        DATE:  March 30, 2021

        TIME:  08:00am PDT


        In this talk, we will discuss the value of moving towards modular and automated, closed-system technologies designed to enable scalable and cost-effective manufacturing. We will highlight the Gibco CTS Rotea Counterflow Centrifugation System, a revolutionary benchtop, closed system which offers exceptional flexibility for cell washing, concentration, and separation by size, with high cell recovery and throughput rate. The compact footprint, process flexibility, and sterile single-use kit allow the system to seamlessly scale with your process, from research through clinical manufacturing.

        Also learn more about how ViaCyte, a clinical stage regenerative medicine company, is focused on delivering novel stem cell-derived pancreatic cell replacement therapies as a functional cure for diabetes. Producing the stem cells required to support development of these therapies and future commercial demand requires an aggressive scale-up effort. As part of this effort, stem cell aggregation, expansion and differentiation processes are being adapted to suspension bioreactor culture. The Gibco CTS Rotea Counterflow Centrifugation System is currently being optimized to integrate with these bioreactors to form a closed, scalable environment for aggregate collection and media exchange. Join us as ViaCyte details how they used the Rotea system to preserve aggregate integrity, morphology, viability, and recovery after processing, and have successfully processed repeated batch feeds on a 3L bioreactor system.

        ViaCyte | Regenerative Medicine Therapies for Diabetes

        ViaCyte is a privately held regenerative medicine company developing novel cell replacement therapies based on two major technological advances: cell replacement therapies derived from pluripotent stem cells and medical device systems for cell encapsulation and implantation. ViaCyte has the opportunity to use each technology individually or together to address critical human diseases and disorders that can potentially be treated by replacing lost or malfunctioning cells or proteins. The company’s first product candidates are being developed as potential long-term treatments for type 1 diabetes patients to achieve glucose control targets and reduce the risk of hypoglycemia and diabetes-related complications. To accelerate and expand the company’s efforts, ViaCyte has established collaborative partnerships with leading companies, including CRISPR Therapeutics and W.L. Gore & Associates. ViaCyte is funded in part by the California Institute for Regenerative Medicine (CIRM) and JDRF. ViaCyte is headquartered in San Diego, California. 


        Learning Objectives:

        • Discuss the current challenges in cell therapy manufacturing and how closed manufacturing systems, such as the Gibco CTS Rotea System, are designed to overcome these challenges and enable GMP-compliant manufacturing processes.

        • Interperet how the Gibco CTS Rotea System utilizes the proven counterflow centrifugation method to enable exceptional performance for cell therapy development from research through commercial manufacturing.

        • Explore how ViaCyte is optimizing the Rotea system to process stem cell aggregates in bioreactors as part of a cell therapy scale-up effort.


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