Scaling up/out: cost-effective and robust transitioning through the clinic to commercial manufacture
GUEST EDITOR: Jan Thirkettle, Chief Development Officer, Freeline Therapeutics
- Examining current trends in in-house and outsourced manufacture – where is the cell & gene therapy space heading, and why?
- Where are the key opportunities to target cost of goods reductions in both cell therapy and gene therapy today? How to capitalise upon them?
- In process and release testing – how are next-generation analytics driving improvements in product quality and accelerating manufacturing timelines?
- How to demonstrate comparability with both cell therapy and gene therapy products through the transitions between early clinical, pivotal trial and commercial phases?
- Continuous manufacture: is it likely to impact the cell & gene therapy space? If so, how and where?
- Standardisation: what are the critical next steps to further enable cell & gene therapy manufacturing? COMING IN SEPTEMBER 2020