Article | August 24, 2017

Early CMC Work Sets Groundwork For Regulatory Success

Source: Patheon

Early CMC Work Sets Groundwork For Regulatory Success

Virtual biotechs often operate with a lean staff that has deep roots in molecule discovery and early research. While this model is attractive from a financial point of view, it creates gaps in chemistry, manufacturing, and controls (CMC) know-how and regulatory expertise. This situation poses risks as molecules progress toward commercialization. Without a thorough understanding of FDA’s expectations for process development data, companies may not collect adequate data in early stages.

If insufficient information is presented to FDA in an Investigational New Drug (IND) filing, the agency will stop the project from moving forward until more data are collected.

Clearly, the more support and guidance small biopharmaceutical companies receive in terms of CMC expertise, the better groundwork it will lay for a successful IND filing.