The last decade of small-molecule process development has witnessed increasing molecular complexity of clinical development candidates. The Mcl1 inhibitor AMG 397, is a recent example of this trend of increasing complexity for clinical candidates. The continued advance of novel synthetic methods and subsequent translation to efficient and scalable processes has enabled process chemists to overcome the challenges associated with this increasing complexity, and to deliver processes that meet the criteria for sustainability and green chemistry. The presentation will highlight case studies from the Amgen Process Chemistry laboratories.

Molecular complexity as a driver for innovation in pharmaceutical process development

ACS Spring 2022

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