It may seem obvious, but not all drugs are manufacturable. Getting an exciting new treatment from the lab to patients is only possible if the molecule or substance itself is scalable.
In this episode of Dose of Discovery, hosts Søren and AJ speak to Cheng Yi Chen, chief technology officer at Asymchem, about the chemistry, scaling up, and decision making behind moving a drug from clinical trials to commercial supply.
Cheng Yi shares the story of cancer drug adagrasib and the urgent supply challenge he faced at Mirati Therapeutics, when the original process couldn’t generate enough of the drug to support clinical trials.
Their conversation then turns to the broader world of process chemistry: how process routes are designed, the regulatory pathways they must follow, and sustainability issues they face.
They also discuss flow chemistry, continuous manufacturing, and why CDMOs play such an important role in helping new medicines reach patients – especially when it comes to dealing with regulators.
In this episode:
About the guest
Cheng Yi Chen is the chief technology officer at Asymchem. He has held senior process chemistry and drug development roles across Merck, Janssen, Mirati Therapeutics, and Bristol Myers Squibb. His work focuses on developing and manufacturing drug substances and products at scale.
Dose of Discovery is cohosted by Søren Hough and Ayokunmi Ajetunmobi (AJ) and produced by Suze Cooper.
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You can find a fully annotated transcript of the episode here.
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