Speakers

Presentation Title: Working with CMOs to Develop a Robust Manufacturing Strategy for Recombinant Virus Vectors

Abstract: At GenSight Biologics, we have been working to accelerate cycle times and manage regulatory compliance from early development (preclinical to first- in- man) to commercial to provide to the patients beneficial solutions for counteracting the effect of rare and irreversible vision loss that can lead to legal blindness in very short time after the onset of the disease.

This presentation highlights the CMC strategy we have developed in the context of operational outsourcing to key suppliers including analytical, process development, manufacturing, and supply chain.

The execution part of a strategy is the critical and requires not only manufacturing capacities but also a successful integration of the process and analytical development sciences, the quality systems that apply to all aspects of GMP manufacturing and an acute understanding of the regulators expectations. All along our Pharmaceutical Development, we have been focusing on supplying in due time the clinical grade material for trials, demonstrating the product comparability and providing process consistency assurance for marketing application. Building a collaborative partnership in this context is a key success factor.