Chemistry, Manufacturing, and Controls (CMC) is often viewed as a regulatory requirement, but could it also be one of the biggest competitive advantages for a cell or gene therapy company? In this episode, host Krista Lamb sits down with Katy Spink and Craig Beasley to explore why CMC should be considered a strategic business function from the earliest stages of development.
The conversation covers what CMC means in the context of advanced therapies, how a CMC strategy should evolve from discovery through commercialization, and the common pitfalls companies face when they treat CMC as an afterthought.
Katy and Craig also discuss how regulators’ expectations are changing, the trade-offs between building internal expertise and leveraging external partners, and why investing in robust CMC capabilities can help companies reduce risk, accelerate development and build long-term value.
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