Accelerating Clinical Readiness for Personalized Cancer Vaccines: A Pragmatic Approach to Manufacturing and Trial Design
- How to take a focused, phase-appropriate approach to process development that supports scalability and GMP compliance for personalized vaccines?
- Leveraging an Investigator-Sponsored Trial (IST) strategy to accelerate first-in-human timelines while managing regulatory complexity?
- Enabling reliable batch production using streamlined release and stability testing tailored to individualized dosing?
NOVEL MRNA MODALITY