A Proven Approach To Impurity Control Across API And RSM Synthesis

To develop high-quality, safe, and efficacious therapeutics for patients, drug developers must work to ensure impurity control across all stages of development and manufacturing. Working with an experienced CDMO that has robust chemistry understanding and extensive manufacturing experience is a critical step to building a thorough impurity control approach. At Grace Fine Chemical Manufacturing Services, expert teams collaborate across all stages of development to establish a thorough impurity profile control strategy to guarantee a high-quality product; this includes process R&D, analytical services, and engineering departments.

In the following Q&A with Robert Hughes, Research and Development (R&D) Fellow at Grace, he considers the vital importance of a consistent project team, tried-and-true approaches for identifying and controlling impurities, and critical steps for building a reliable supply chain. If you are interested in learning more about how a knowledgeable CDMO approaches impurity control throughout all stages of manufacture, download the full article.