02.24.26 -- At JP Morgan 2026, Few Showed Up For U.S. Manufacturing

RMAT qualification requires preliminary clinical evidence demonstrating the potential to address an unmet medical need. This designation grants benefits like intensive guidance and faster FDA review.

Economic pressures, funding shifts, and evolving therapeutic pipelines are reshaping CDMO capacity, with 2026 expected to bring intensified competition and strategic realignments.

Learn how predictive models can monitor key CQAs, such as RNA concentration and nucleoside triphosphate consumption, and explore RBP and MIT’s vision for revolutionizing biomanufacturing.

As the field evolves, the strategies developers choose may prove just as influential as the therapies themselves in determining how quickly innovation reaches patients.

This platform enables high-yield AAV manufacturing with minimal contamination, delivering >10¹⁷ genome copies per 200L run and supporting efficient, GMP-compliant production for diverse serotypes.

Managing timelines to IND is the top challenge in cell therapy, impacting funding, patent value, and patient access amid competitive, capital-constrained development environments.

Discover how one family's collaboration with a specialized CDMO enabled the rapid development of a life-saving gene therapy for their daughter diagnosed with an ultra-rare disease.

Streamlining the tech transfer process is a key variable in shortening development timelines and controlling costs, maximizing a molecule's potential for late-stage success.

For the robust AA6 serotype manufacturing, this production platform offers proven reliability and scalability, making it well suited to meet the demands of large-scale operations.