Control API Impurities To Achieve Therapeutic Safety And Efficacy For Patients

By Robert Hughes, Research and Development (R&D) Fellow, W. R. Grace & Co.

Delivering safe, high-quality, and efficacious therapeutics to patients is the utmost goal of drug development; to make this possible, sponsors and their manufacturing partners must prioritize impurity control across development and manufacturing. Impurities entail any substances present beyond the API, and they can arise from a number of sources, including regulatory starting materials, production processes, and manufacturing equipment. Without proper impurity control, impurities can negatively impact the quality, safety, and efficacy of an API, leading to adverse reactions, toxicity, or long-term health risks for patients.

In your search for the ideal CDMO, prioritize finding a partner that leverages a robust approach to impurity management for APIs and RSMs. An experienced partner will be adept at navigating regulatory guidelines, leveraging analytical technologies, and implementing QbD approaches. Furthermore, their R&D, analytical, engineering, and quality teams will understand how to establish an integrated approach to impurity control. Download the full white paper to gain more insight into how an experienced CDMO establishes robust impurity control throughout manufacturing.