The California Institute for Regenerative Medicine (CIRM) has set goals through its five-year strategic plan to continue to deliver the full potential of regenerative medicine to the people of California and around the world.
One of those goals is to overcome manufacturing hurdles for the delivery of regenerative medicine therapies by building a public-private manufacturing partnership network.
This is essential because the field needs to create standardized manufacturing processes to transition from the production of smaller batches of therapies for use in clinical trials, to the larger batches required by full-scale commercialization. The manufacturing process for cell and gene therapies is more complex than for other biologics, so CIRM is committed to creating a network to overcome those challenges.
In working towards that goal, CIRM is pleased to announce a new funding opportunity within our Infrastructure Program, the INFR5 Cell and Gene Therapy Manufacturing Network (Phase 1) Awards.
The California Cell and Gene Therapy Manufacturing Network aims to establish a statewide manufacturing network comprising academic process development and GMP manufacturing facilities as well as industry manufacturing partners that will:
- Accelerate and de-risk pathways to commercialization for cell and gene therapies
- Advance industry standards and incorporate quality-by-design in cell and gene therapy manufacturing, and
- Build a diverse, highly skilled manufacturing workforce in California.
CIRM will issue two phases of awards governed by two separate requests for applications (RFAs). This RFA describes the first phase of awards that will fund California academic cell and gene therapy GMP manufacturing facilities to make initial progress toward the three network goals (described above) at their individual facilities.
To apply for this award, please visit our website to download the Program Announcement and access a link to the application.
Update: If you’re interested in learning more about the INFR5 Phase 1 Awards, eligibility requirements, the application and review process, and more, the CIRM team hosted an informational webinar in November. Watch a video recording of the webinar here. The slide deck is available here.