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24 Jun 2021Ended

Challenges and processes for development and scale-up of stem cell therapies

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Jun 2021

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GMP cell manufacturing for new clinical cell therapies is a rapidly expanding need in the life science space. This presentation will discuss the .. Read more foundation of cell therapy product development considerations when preparing to launch into manufacture of materials in support of early Phase clinical trials to commercialization. Historical development of an autologous canine mesenchymal stem-cell product that facilitated the ability to rapidly respond to develop and manufacture an allogeneic human MSC product for treatment of COVID-19 patients with ARDS will be presented. Building upon years of experience, in 2020 PSC submitted and IND for approval, rapidly developed and manufactured an allogeneic Phase I/IIa human mesenchymal stem cell therapy product. Upon FDA approval, this product was licensed and subsequently taken into clinical trial use in the treatment of COVID-19 patients suffering from ARDS. This product recently finished Phase Ib under the product name COVI-MSC and demonstrated a 100% hospital discharge rate. As an expert in cell therapy manufacturing, her team also provides contract product development and manufacturing services as Performance Cell Manufacturing for manufactured cells used directly or in support of cell therapy products in clinical trials.

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Cambridge Healthtech Institute

USA237 Total Events / 39 Upcoming Events

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