Mastering CDMO Selection: Matching your API's Chemistry for Scale-Up Success

A report from the Lets Talk session on 14th May 2025. Moderated by Dr Urvish Pandya

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A transcript of the conversation is shown below.

(There were no slides used for this session)

• Introduction: Claude introduced the session and welcomed Dr. Urvish Pandya as the moderator, highlighting his extensive experience in chemical development and API scale-up.

• CDMO Selection: Urvish discussed the complexities of CDMO selection, comparing it to matchmaking and cooking. He emphasized the importance of understanding the chemistry and the equipment to ensure a good fit and avoid costly mistakes.

• Nitration Example: Urvish provided an example of scaling up nitration, highlighting the challenges faced due to reactor volume and headspace. He stressed the importance of understanding the equipment and chemistry in detail to avoid failures.

• CDMO Challenges: David shared his perspective as a CDMO representative, discussing the challenges of balancing risk and customer expectations. He emphasized the importance of understanding the customer's appetite for risk and providing a de-risked program.

• Prioritization: Urvish and David discussed the prioritization of projects within CDMOs, noting that more valued projects often get priority. They highlighted the importance of managing resources effectively to keep costs down and deliver the best results.

• Technical Team Involvement: John raised the importance of involving the technical team in the CDMO selection process to ensure a realistic assessment of capabilities. Urvish agreed, sharing his experience of situations where the technical team provided valuable insights.

• Risk Assessment: John suggested making formal risk assessment a part of the proposal stage, involving the CDMO in identifying risks. David added that CDMOs are good at identifying risks, but customers need to express their appetite for risk clearly. Urvish concurred with the strategy, albeit acknowledging that such an exercise would necessitate time and effort, thereby incurring costs, it is unlikely that CDMOs would undertake such activity at no charge.

• Communication: Gayle emphasized the importance of clear and direct communication with CDMOs, noting that easy communication and dealing with one person are key factors in their selection process.

• Pitfalls to Avoid: Urvish summarized the pitfalls to avoid, including not taking the CDMO's word literally, considering costs carefully, and gathering as much information as possible during the preclinical stage.

• Meeting Conclusion: Claude concluded the meeting, thanking Urvish for facilitating the session and highlighting the importance of involving experienced consultants to avoid pitfalls and save time and costs.

Any questions? Please get in touch: claude.houet@phetairos.com or John.faulkes@pipmg.org