The second installment in a three-part series exploring the challenges and considerations for cell and gene therapy development, from bench through commercial supply.
- Early development – using the right material
- Translation from development to clinic – reducing risk and timelines
- Clinical to commercial – scalability and supply chain simplification
The successful outcome of pre-clinical studies on vectors generated from research grade (non-GMP) plasmids provides the basis for the progression into first-in-human studies, and therefore represents a critical milestone in the product’s development. It also represents a change in terms of the management of a project, the regulatory environment in which it is performed, and the people and skills required from both a client and plasmid supplier perspective.
Future-proofing products with strategies that reduce risk and timelines for later stages can be resource-intensive but add significant value. In this follow-on whitepaper we explore the challenges often encountered progressing from development to clinic.
Read Part 1 here.