How A Specialized CDMO De-Risks Complex API Development

By Tobias Haag and Jason Modest, MilliporeSigma

A specialized CDMO offering flexibility, depth of expertise, and a proven track record is often the most appropriate partner to help guide a complex API program or first-in-class therapy to market. Specialized CDMOs have become a necessity as modern medicine trends more toward targeted therapies and personalized medicine, which often comprise complex and/or high-potency APIs (HPAPIs).

Moreover, first-in-class therapies tend to require numerous synthesis steps and to function using novel mechanisms of action. These attributes often are driven by hazardous or chiral chemistry, but not all CDMOs have the ability or experience to effectively handle those compounds.

A specialized CDMO is set apart by distinct experience working with complex API molecule classes and process characteristics: for example, its training practices specific to working with hazardous materials, the way its facilities and personnel are outfitted, and its aptitude in navigating difficult regulatory terrain.

In addition to core competencies that help minimize risk and delays throughout development, a specialized CDMO has processes in place capable of meeting the aggressive timelines associated with drugs based on HPAPIs, especially first-in-class therapies, which are often filed under fast-track, orphan designations. Demonstrable complex API experience in a CDMO is also relevant to regulatory guidance, since most first-in-class therapies lack a well-established regulatory path.