Taking Your Advanced Therapy From Clinic To Commercialization: Planning For Success

The final 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

In A Guide to Plasmid Selection in Drug Discovery: Starting with the End in Mind and Navigating the Translation to Clinic: Future-Proof your Plasmid Products, the transition from the manufacturing of plasmid DNA for the production of vectors for discovery applications, to the manufacturing of vectors for clinical use and the associated operational and regulatory challenges were discussed.

Progressing your cell or gene therapy program from clinic to commercial can bring significant change. In this follow-on paper we explore the shifts in focus for quality systems and manufacturing processes, as well as highlight the importance of establishing long-term supply chains, starting with the end in mind.