Solid-State Characterization Of A Small Molecule API

Developing a new drug is a complex process, and ensuring the consistency and purity of the active ingredient is paramount. This case study details how Alcami, a contract research organization (CRO), collaborated with a client to achieve this critical goal for their small molecule drug candidate. Tight deadlines and unexpected discoveries about the material's solid-state properties presented challenges.

Alcami's expertise in solid-state characterization played a key role. Through advanced techniques, they identified a new hydrated form of the drug (Form 2) that could have jeopardized its stability and production. Scientists then conducted a comprehensive polymorph screen, revealing a new stable anhydrous form (Form 3) and recommending adjustments to the manufacturing process to favor the desired Form 1.

This close collaboration ensured the timely completion of the Investigational New Drug (IND) application, laying the groundwork for future clinical trials. It also led to the filing of a patent application to protect the intellectual property of the newly discovered forms. Learn about the importance of CRO partnerships in navigating the intricate world of pharmaceutical development, especially when facing tight deadlines and complex scientific hurdles.