A biotech client engaged Piramal Pharma Solutions’ Riverview, Michigan drug substance facility to develop and manufacture a complex payload-linker intended to feed multiple antibody-drug conjugate (ADC) programs. The inherited six-step synthesis relied heavily on costly preparative high-performance liquid chromatography (prep HPLC), suffered from sticky, poorly soluble intermediates, and involved sensitive, unstable chemistry in later stages. An expensive, highly potent compound introduced in the first step placed a premium on getting downstream chemistry, purification, and isolation right, all against an aggressive clinical timeline.
Piramal redesigned the six-step synthesis stage by stage, carrying the Step 1 racemic, non- GMP intermediate into GMP manufacture at Steps 2 to 6. The goal was to replace preparative HPLC with optimized workups where procedures allowed, resolve handling and stability liabilities, and deliver consistent, high-purity material at scale to support clinical supply.
