Bringing you the latest cutting-edge research and commentary in bioscience.

Cell & Gene Therapy Insights

Cell & Gene Therapy Insights

Perspective
Spotlight Article

How to effectively manage critical raw materials to support clinical development in CAR-T cell therapy

Raw and Starting Materials

Emilie Gauthy, Laure Lambricht & Sarah Snykers

In CAR-T cell therapy, one of the main challenges to obtaining a consistent, reproducible manufacturing process and therapeutic product is the variation of the cellular starting material. However, one should not overlook the importance of raw materials. Proper selection and control of raw materials and their suppliers/manufacturers are critical moving forward during clinical development. It will impact process and product quality, safety, consistency, but also support continuous manufacturing and cost of goods control. In this opinion piece, we describe based on our experience a practical and effective risk-based tool to prioritize effort towards raw materials during clinical development. This approach should help identifying weaknesses and establish an action plan to prepare for commercial raw material readiness.

DOI: 10.18609/cgti.2019.017
Citation: Cell & Gene Therapy Insights 2019; 5(2), 133-140.
Open access
This content is restricted to registered users. Click here to Register or Login here.
Twitter IconVisit Our Blog