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Addressing scalability challenges in the development and manufacture of gene therapies
Viral Vectors have been approved for use in gene therapies, gene modified cell therapies, and vaccines to address rare disease, cancer and public health issues.
These products are moving to commercialization quickly and often require large quantities of vector (systemic rare disease treatments, COVID vaccines)
The speed these products are moving through clinical development is putting added pressure on CMC and there are challenges demonstrating robust processes and comparability to materials generated in early phase trials.
There is heavy reliance on single use technology to manufacture these products and supply chain challenges are constraining manufacturing.
In this presentation, we will discuss these focus areas on the road to commercialization and how Thermo Fisher Scientific is addressing this to enable innovators to meet patient needs.