Is Your API Ready For Scale-Up? What To Demand From Your CDMO

By Justin A. Divan, Manager, Project Management, Pfizer CentreOne

A CDMO that can optimize your API synthesis process early during technology transfer will reduce the risk of project delay or failure. That will also help your molecule run more efficiently in their plant. And time is money.

Most medicinal chemists design novel active pharmaceutical ingredients (APIs) to secure a patent and IP protection, not to create a scalable production process. That makes sense. They are racing against the clock, running through failures before they achieve success. Fine-tuning comes later.

When the technology is transferred into a production environment, a synthesis proven in the laboratory often doesn’t work at full scale. The synthesis route can be subject to process failures, or the process may not be efficient at commercial scale.

If you work with a contract development and manufacturing organization (CDMO), you need to know they can safely scale up your process and manufacture your compound efficiently. That work starts at tech transfer.