Making the Medicine: Cheng Yi Chen on Scaling Drugs from Lab to Launch

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:03:48 – Explainer: What are CDMOs?06:50 – Introducing Cheng Yi Chen07:09 – The adagrasib supply challenge at Mirati11:19 – How process chemistry enables clinical progress16:57 – Moving between big pharma, biotech, and CDMOs work27:06 – Peptides, oligos, and the rise of TIDES manufacturing30:44 – Green chemistry, solvents, and cost-effective production36:56 – Flow chemistry and continuous manufacturing44:50 – Creating a manufacturing story for regulators39:48 – China’s growing role in biotech innovation47:57 – Wrap-up and key takeawaysAbout the guestCheng 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.LINKS:GLP-1s forced industry’s hand on sustainable peptide synthesis, says expert by Søren Hough (Interview with Fernando Albericio) Enzymes open the door for simpler, more efficient oligo therapeutic synthesis by Søren HoughAdaptable manufacturing platforms enable in vivo mRNA-LNP delivery by Søren HoughIndustry pioneers solve the ‘three-body problem’ of RNA synthesis by Søren HoughEli Lilly’s Michael Kopach says retatrutide leads in obesity treatment and CMC innovation by Søren HoughRead more at Bioxconomy, sign up to our newsletter, and don’t forget to check out our upcoming events.You can find a fully annotated transcript of the episode here. Hosted on Acast. See acast.com/privacy for more information.