Quality by Design Planning in ATMPs: A Guide to Selecting the Right Starting Materials
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Quality by Design Planning in ATMPs: A Guide to Selecting the Right Starting Materials

Quality by Design Planning in ATMPs

Advanced therapy medicinal products (ATMPs) represent a new frontier in precision medicine. From cancer cures to treatments for “untreatable” genetic disorders, they’re poised to define the next generation of medical care.

However, finding ways to ensure the safety and efficacy of these novel therapies, all while speeding time to market, is critical to deliver on the promise of ATMPs. That starts with sourcing the optimal raw materials: ones that lay the foundation for consistent processes that yield effective and safe therapeutics and help developers avoid costly delays that slow time to market — or, worse, sink their program entirely.

In this guide, learn how CDMOs and therapeutic firms can evaluate their needs and select the raw and cellular starting materials that will set their programs up for success. Learn how raw materials affect the consistency of your process and product, what the essential components of a robust GMP framework are, and which strategies help you find a trusted vendor that can propel your program forward. Download now to learn more.

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