Gain insights into T-cell expansion, viral vector production and scaling production of mesenchymal stem cells (MSCs) through the use of a functionally closed, automated cell culture process.
Dr. Beltzer presents several case studies describing how process development and economic goals were achieved in industry and academic settings. Results include a 500-fold expansion of T-cells in 12 days, 40 percent reduction in cost of goods (COGs) of growing cells for an allogeneic cell therapy and automated viral vector production with titers similar to flask-based processes. Particular attention will be directed toward the process changes often needed to meet these goals.
In this webinar, you will:
Jim Beltzer, PhD
Senior Cell Processing Specialist,
Terumo BCT (Colorado, U.S.)
Jim earned his PhD in biochemistry at Purdue University and completed his post-doctoral fellowship at the Biocenter in Basel, Switzerland. He worked at several start-up biotechnology companies in the Boston area and at Corning Life Sciences prior to joining the cell processing team at Terumo BCT. He has more than 25 years of research and development experience in a broad range of disciplines.
To transform the promise of cell-based therapies into reality, a robust and scalable process is required to be compliant with current good manufacturing practice (cGMP) regulations. From clinical to commercial manufacturing, processes need to produce progressively larger batches with consistent product quality.
Developing these processes may allow affordable and sustainable therapies to reach the market more quickly. Here we present a case study from the large-scale expansion of a process using human stem cells obtained from adult bone marrow.
Amel Tounsi, PhD
Development and Project Manager,
MaSTherCell (Gosselies, Belgium)
After receiving a master’s degree at the Université Louis-Pasteur in France, Amel Tounsi obtained her PhD in immunology and cellular biology at UCL (Université catholique de Louvain) in Brussels. She then completed a postdoctoral fellowship at a German cancer research center where she worked on the establishment of in vivo models in mice to study the immune-regulatory activity of bone-marrow-derived mesenchymal stem cells. After her academic experience, she joined the research and development (R&D) department of Cardio3 Biosciences (now called Celyad), a Belgian biotech company developing a stem cell therapy for the treatment of chronic heart failure. Amel was involved in process improvement and developed release and potency assays. Her expertise in academia, R&D and the biotech industry was an asset for MaSTherCell, where she has worked as development and project manager since August 2014.
This white paper demonstrates how the Quantum system provides a functionally closed, automated and scalable expansion method to generate clinically relevant yields of MSCs from whole bone marrow and precultured cells on the Quantum system utilizing fibronectin or cryoprecipitate as an adhesion promoter.
Specifically, this case study outlines how the efficient use of both human and facility resources maintained a cost savings of 40 percent relative to manual manufacturing methods.
This white paper demonstrates the expansion of T-cells in the Quantum system. Results from a single stimulation event showed that the Quantum system produced 90- to 500-fold expansion of T-cells starting from an apheresis blood collection in as little as 13 days.
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