Key Takeaways from Phacilitate Leaders World: World Stem Cells Summit 2019
One of the overarching themes of the Phacilitate conference this year was bringing down the cost of goods so cell and gene therapy (CGT) treatments will be more affordable. While “affordability” is relative in that the price for CGT’s, which is typically a single treatment, must be compared to a lifetime of enzyme replacement or cancer treatment, there is no doubt we still have plenty of opportunity to streamline the manufacturing and testing processes and reduce development costs. In order to realize these efficiencies, innovation is needed at all stages, from R&D developing less expensive delivery systems and more predictive analytical tools, to CDMO’s establishing GMP-grade supply chains and scale-up capabilities for complex biological products.
Overall, these challenges are good for the industry because it means the therapies are working. Now that we have seen commercial success with the likes of Kymriah, Yescarta, and Luxturna, we must learn from other established therapeutic modalities, like monoclonal antibodies and pharmaceuticals, to improve efficiencies with regards to supply chain, automation, manufacturing, and standards.
Absorption Systems has the expertise and relevant experience needed to provide analytical support for gene and cell therapy products through every stage of development. Potency assays are on the critical path and ABS offers de novo development, optimization, qualification, validation and GMP compliant final product and product release testing services for both allogenic and autologous therapies.
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