07.03.24 -- Strategies To Tackle CAR-T Product Challenges

In addition to codifying some best practices, R3 recommends that sponsors adopt an approach to identifying and managing areas of risk to mitigate potential issues and enhance overall success.

The FDA has launched an investigation into the risk of T-cell malignancies following CAR-T cell immunotherapies. Review the key points of this announcement concerning the CGT research community.

See how pharmaceutical companies that can mitigate financial risk for CGT providers and ease cash flow burdens will stand out as preferred partners in an increasingly competitive industry.

It is crucial to monitor the IP landscape and file patent applications for advancements. By staying informed and proactive, companies can secure their position in the rapidly evolving CGT field.

Understanding how to develop and use quality control assays is crucial for ensuring product quality, optimizing processes, and fostering continuous improvement and customer satisfaction.

Choosing the CDMO best suited to manufacture your rare disease therapy can be challenging. Ideally, a CDMO will prioritize your goals while working to ensure quality and regulatory success.