Changing a critical starting material, whether driven by supply chain risk, a new supplier, process improvement or obsolescence, can be the most consequential decision a manufacturer can make. It touches everything from analytical comparability to stability data, regulatory strategy and timelines. Therefore, these changes require robust scientific justification and a well-planned CMC strategy.
In this webinar hosted by 4basebio, Sandeep Yadav, VP CMC Technical Development at Sangamo Therapeutics, explore what's really involved in preparing a regulatory submission to support a critical starting material change. Drawing on real-world experience, they'll discuss how to build a scientifically sound, risk-based justification that satisfies regulators while keeping development programs on track.
Whether responding to an imposed supplier change, planning for commercial scale-up or simply to understand how regulators assess these changes, this webinar will provide practical insights and a clear framework to help navigate critical starting material changes with confidence.
Register for this webinar to learn how to strengthen CMC submissions for critical starting material changes, understand regulatory expectations and develop a practical, risk-based approach that supports successful regulatory outcomes.
Who Should Attend
This webinar is ideal for CMC, regulatory and technical professionals involved in the development and manufacture of cell and gene therapies, nucleic acid therapeutics and other next-generation therapeutics, including:
CMC and Regulatory Affairs professionals
Process Development and Manufacturing Scientists
Analytical Development and Quality professionals
Technical and Project leaders responsible for CMC strategy, process changes and lifecycle management
What You Will Learn
Attendees will gain insight into:
How to define and justify a critical starting material, and why this classification shapes CMC strategy and regulatory pathways
What regulators expect in a robust submission, including comparability data, risk assessments and the scientific evidence needed to support a critical starting material change
How to avoid common regulatory pitfalls by structuring an effective CMC submission, communicating proactively with regulatory agencies and understanding differences in expectations across agencies such as the FDA and EMA
How to plan for successful implementation, with practical guidance on managing timelines and navigating unavoidable or urgent starting material changes
Register free on Xtalks:
https://xtalks.com/webinars/future-proofing-your-cmc-strategy-managing-critical-starting-material-changes/
