Allucent Blog Cell Therapy Manufacturing: Analytical Testing, Validation, and Regulatory Considerations

Developing cell and gene therapy products (CGT) presents unique challenges, particularly in manufacturing and quality control (Chemistry, Manufacturing, Controls - CMC). Sponsors must adopt a proactive approach to problem-solving and risk assessment to avoid clinical holds and program delays. This is especially critical for autologous cell therapies, where only one batch of starting material is [...]The post Cell Therapy Manufacturing: Analytical Testing, Validation, and Regulatory Considerations appeared first on Allucent.