Strategic CMC Considerations For Pre-IND Meetings: Setting The Stage For A Successful TPP

In the high-stakes world of biotechnology, the Pre-Investigational New Drug (Pre-IND) stage is a critical juncture, particularly for companies venturing into the complex realm of cell and gene therapies (CGT). This article underscores the pivotal role of Chemistry, Manufacturing, and Controls (CMC) in navigating this phase, where overlooking CMC can spell disaster in the form of regulatory delays and stalled clinical trials. It highlights essential CMC components, such as defining Critical Quality Attributes (CQAs) like identity, purity, and potency, ensuring raw material traceability, and maintaining sterility throughout manufacturing.

The piece emphasizes the importance of aligning stability and shelf-life planning with dosing protocols and developing robust analytical methods to validate efficacy. By crafting a comprehensive CMC strategy that harmonizes with the Target Product Profile (TPP), biotech firms can enhance regulatory compliance and pave the way for commercial success. Concluding with insights from Ergomed, the article advocates for early CMC planning and documentation to mitigate regulatory risks and foster effective Pre-IND discussions, ultimately driving innovation in the biotech landscape.