From Risk To Readiness: How Smart CMC Strategy Defines Advanced Therapy Success

Advanced therapies inherently present significant manufacturing and quality hurdles, and delays stemming from Chemistry, Manufacturing, and Controls (CMC) issues are common. Success requires moving past transactional vendor relationships and embracing a collaborative, phase-appropriate CMC strategy that aligns directly with clinical development milestones.

A critical component is establishing a Quality by Design (QbD) mindset early on. This systematic approach is essential for identifying and closing gaps in product and process understanding—even for complex modalities where Critical Quality Attributes (CQAs) are initially unclear—which helps de-risk the program overall. Furthermore, developers must proactively manage regulatory interactions, strategically utilizing early meetings to gain feedback on complex issues like setting comparability acceptance criteria or managing lot stability ahead of Biologics License Application (BLA) filings.

Learn how strategic planning, early partner engagement, and a QbD framework are essential tools that mitigate risk and accelerate your advanced therapy program toward commercial readiness.