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.
In this webinar, you will:
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.
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