Development of scalable and robust processes for small molecule payloads utilized in ADC based therapies represents a unique challenge for today's process chemists. In addition to the inherent safety related issues with regard to handling highly potent materials, process development of ADC payloads presents challenges that are distinct from typical small molecule based therapies. In many cases these compounds are considerably larger and therefore require longer routes of synthesis which can be a burden in terms of material throughput, manufacturing time, and the breadth of development required to prepare for scale-up. In addition, structural features such as highly polar structural moieties and a large number of stereogenic centers can contribute to the challenge of isolating, characterizing, and developing a control strategy for these molecules. This presentation will touch on how the process development group at Seattle Genetics has addressed some of these issues.

Process development of highly potent cytotoxic drug-linker payloads

256th National Meeting (2018)

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