Taking Full Advantage of Service Providers

Posted: 1 April 2024

Outsourcing clinical trial material (CTM) manufacturing allows drug developers to immediately access an experienced team and existing capacity and thus avoid significant investments while also allowing them to focus on discovery and development. It is most efficient to work with an outsourcing partner that offers not only product manufacturing, but the full complement of required analytical testing and comprehensive packaging services. However, having a second provider is recommended as way to mitigate supply-chain risks.

Finding end-to-end providers in the advanced therapy space can be challenging, however. When supporting clinical trials in multiple locations around the world, there may also be specific requirements for local CTM supply and/or performance of certain analytical studies (e.g., stability testing), as well as specific facility and other requirements or regulatory expectations that must be met.

When choosing a cell and gene therapy CDMO, it is important to consider the expertise of the firm and its level of commitment to quality, and whether they have a flexible platform technology that includes comprehensive analytics and method development capabilities. The provider must also have available capacity, the ability to complete tech transfers and perform comparability exercises, platform modularity and adaptability, and human expertise (capability) to meet customer needs and ensure risk mitigation throughout the life of the product.