A case study review on large-scale manufacturing of stem cell therapies
Live event: Tuesday, February 21, 2017 at 07:00 [PST] 10:00 [EST] 15:00 [GMT]. To transform the promises of cell-based therapies into reality, a robust and scalable process is required to be compliant with cGMP regulations.
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To transform the promises of cell-based therapies into reality, a robust and scalable process is required to be compliant with cGMP regulations. From clinical to commercial manufacturing, processes need to produce progressively larger batches with consistent product quality.
By accomplishing these processes, it can make affordable and sustainable therapies reach the market more quickly. Here we present a case study from the large scale development expansion of a process using human stem cells obtained from adult bone marrow.
What will you learn?
- An example of a process that was used to scale out an allogeneic cell therapy, based on a comprehensive look at a case study
- The advantage of using bioreactors for cell therapy manufacturing
Who may this interest?
- Clinicians, researchers, lab technologists and cell therapy industry professionals
- Cell therapy manufacturing professionals
Amel Tounsi, PhD
Development and Project Manager
MaSTherCell (Gosselies, Belgium)
After receiving a master’s degree at the Université Louis-Pasteurin France, Amel Tounsi obtained her PhD in Immunology and Cellular Biology at UCL (Université catholique de Louvain) in Brussels. She then followed a post-doctoral 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.For a full list of other webinars available on RegMedNet please see here.