The VirtualPharm
The VirtualPharm Podcast is an audio series that covers topics related to compliance and regulatory affairs in the Lifesciences industry. Each episode, hosted by experts on the topic with decades of experience, offers listeners detailed insight into the changing regulatory environment. The podcast provides timely information about emerging regulations, legal updates, industry insights, and best practices for organizations. The episodes are informative and engaging, helping educate professionals on remaining compliant while staying agile in their industry.
The VirtualPharm
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.