The Role of API Process Development in CMC Drug Development

This Podcast discusses the critical role of API process development in the Chemistry, Manufacturing, and Controls (CMC) drug development process. This process focuses on ensuring the drug substance or API (Active Pharmaceutical Ingredient) can be manufactured consistently and safely at scale. The text explains the different stages of API process development, from the early preclinical phase where synthetic routes are developed, to later stages where these routes are optimized for scalability and cost-effectiveness. The text then explores challenges in API process development, such as the complexity of chemical reactions involved in drug synthesis and the need to balance cost and quality. Finally, the text distinguishes between small molecule APIs and biologics, highlighting the unique complexities associated with each.

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