Gene And Cell Therapy: Planning For Manufacturing Success Early

Over the past decade, gene and cell therapies have transformed from a clinical concept to mainstream reality and attracted high interest despite ongoing challenges related to their production. Producing and characterizing viral vectors — one of the most widely-used delivery devices for gene therapies — is expensive, time consuming, and subject to intense regulatory scrutiny of quality. The need for consistent supply of high-quality starting materials such as plasmid DNA also places constraints on a large portion of the regenerative medicine sector.

Seeking a manufacturing partner with the expertise and ability to scale up and out will not only save time and money now, but it will also help enable breakthroughs to reach patients awaiting these potentially transformational approaches and a better quality of life.

As gene and cell therapy organizations are asked to balance the need for rapid clinical progression and stringent quality expectations throughout development, explore considerations to help optimize plasmid production and reach patients with speed and reduced costs.