Documenting Biodegradation when the Products are Difficult to Discern

The voyage of a cell or gene therapy from initial hypothesis to commercial delivery is complex and challenging. It requires a broad spectrum of scientific expertise, innovative technologies, and optimized processes to ensure these advanced therapeutics make it to market. In this GEN webinar, our panelists—two industry leaders—will discuss what it takes to develop a cell or gene therapy from concept to commercialization, alongside a conversation about innovations that are likely to shape the future of advanced therapy discovery and biomanufacturing.

Cell therapy products have amazing potential to treat a wide variety of diseases and vast numbers of patients globally. However, establishing a scalable manufacturing technology that can reliably reproduce the yield and quality of derived products generated from small-scale R&D methods at larger scales sufficient for commercial manufacturing can pose many challenges.

When a developed virus filtration process is validated by viral clearance testing, the addition of a virus spike for just this purpose can lead to disappointing results.

A Virtual Special Issue of FEMS Yeast Research accompanies the webinar, gathering 19 recent research papers that illustrate the breadth of both fundamental and biotechnology-orientated research going on in the community.