Exploring the capabilities of a versatile, novel, automated closed system for cell and gene therapy manufacturing

Published: 25 March 2021
Innovator Insight
Sarah Daoudi,
Sarah Daoudi
Field Application Scientist, Cell and Gene Therapy at Thermo Fisher Scientific
Sarah Daoudi is a Field Application Scientist that provides solutions and consultation for Thermo Fisher Scientific’s cell and gene therapy workflows and Gibco Cell Therapy Systems (CTS) brand of products. Sarah has expertise in CAR-T workflows, manufacturing, viral vector production (lentivirus and adeno-associated viruses), and drug development. Formerly a Scientist II at Thermo Fisher Scientific, she helped launch the CTS Rotea System by producing application data, writing and developing new protocols, as well as extensive troubleshooting and customer support. In her previous role as Process Development Research Associate at City of Hope (Duarte, California), Sarah oversaw and worked on improving, troubleshooting, and development of Phase I CAR-T cell therapeutic drugs and workflows for over ten different IRBs. Sarah received her master’s degree in Cell and Molecular Biology from California State University, Fullerton (California).
Premkumar Jayaraman
Premkumar Jayaraman
Regional Field Applications Scientist, Cell and Gene Therapy
Dr Premkumar Jayaraman currently provides consultation and training for Thermo Fisher Scientific’s cell and gene therapy solutions such as the Gibco Cell Therapy Systems (CTS) brand of products. Prem has over 7 years of expertise in synthetic biology utilizing gene-editing technologies, stem cell bioprocessing (pluripotent and adult stem cells), and viral vector production (lentivirus and adeno-associated viruses). In his previous role as a Research Scientist at the Bioprocessing Technology Institute (A*STAR, Singapore), Prem oversaw a variety of cell and gene therapy projects, from media optimization to upstream process development. Prem received his doctoral degree in Biotechnology from Nanyang Technological University (Singapore).

As more cell and gene therapies move toward clinical trials, and into commercialization, new trends and challenges are emerging. Technologies and processes are rapidly evolving, and it can be challenging for manufacturers to select the best tools for their unique needs. Focusing on cell therapy manufacture in particular, there is a lack of specific equipment and products, and as such the resulting manufacturing workflows can be highly labor-intensive, often involving open processes and manual manipulations. Closed manufacturing systems, in combination with digital connectivity, can offer a solution to some of these challenges, as these systems enable repeatable, trackable, and GMP-compliant manufacturing processes. This article will discuss the benefits of moving towards modular, closed-system technologies designed for scalable and cost-effective manufacturing, with a focus on the Gibco™ CTS™ Rotea™ Counterflow Centrifugation System – a revolutionary closed benchtop system which offers exceptional flexibility for cell washing, concentration, and separation by size.

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