Raw Material Considerations For Cell Therapies

Choosing the right raw materials is critical for the safety and success of your cell therapy product. These materials are generally split into two categories: raw materials, which are used during manufacturing, and excipients, which are part of the final product. A major challenge for manufacturers is the lack of specific cGMP regulations for sourcing these components. This regulatory gap creates confusion and risk, making it difficult to properly qualify materials.

This article provides a clear overview of the key considerations for selecting raw materials in a way that minimizes risk and aligns with current regulatory expectations from agencies like the FDA. To learn the fundamentals of building a compliant raw material program, continue reading below.