Challenges and Future Directions in CMC

Despite its immense value, scientific data in chemistry, manufacturing, and controls (CMC) remains largely untapped. As a result, biopharma companies are struggling to accelerate timelines and reduce costs during late-phase development. A group of industry experts explored the root causes and how best to address them. This white paper summarizes their key findings.

Inside, you'll learn:

• The top 3 business challenges facing CMC and their underlying causes
• Key areas for future development within CMC
• The industry's readiness for electronic regulatory submissions
• Opportunities for using AI in CMC and their potential impact