The first installment in a three-part whitepaper 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
For many viral vector producers, transient transfection is the preferred route of vector production. Reliable supply of plasmid DNA is critical through all stages of the product life cycle, coding not only for the therapeutic gene and expression elements, but also the vector capsid and required replication genes. As such, production and supply approaches must be designed to meet the demands of the product.
Clinical development milestones are built on the foundations and achievements of previous phases. In this white paper, we discuss the importance of an effective strategy, working backwards from the end-goal: commercialization.