CMC development is often rate limiting for initiation of first in human studies, continuation to late stage development, and ultimately commercialization. The challenge is particularly acute for emerging and rare disease indications. Developing efficient and streamlined CMC strategies are imperative to quickly delivering therapeutics and diagnostics to patients while maintaining patient critical safety and quality standards.
• Strategies for rapid development across CMC functions
• Robust and efficient assay development throughout product lifecycle
• Leveraging past-experience to optimize process development strategies (e.g., process analytical tools)
• Regulatory-CMC considerations for accelerated development
• Diagnostic kit development