Vol 39: The Role of API Process Development in CMC Drug Development: A Comprehensive Overview

In this audiocast, we discuss the role of API (Active Pharmaceutical Ingredient) process development in Chemistry, Manufacturing, and Controls (CMC) drug development, including its importance in ensuring the scalability, quality, and safety of drug manufacturing. It provides an overview of the API process development, associated challenges, and common questions that arise during the clinical phase trials leading to commercialization. The article also compares small molecule APIs and biologics, highlighting their differences in molecular size and complexity, mechanism of action, and manufacturing processes at a high level.