Case Study

"Ultra High" Potency Development And Manufacture

Source: Cambrex
iStock-1242453956-lab-development-scientists-research

Cambrex was approached by a US-based biotechnology company to develop a process for producing a highly potent API, a DNA alkylator, used to treat an unmet oncology need. The biotechnology company had limited experience in the development and manufacture of high potency compounds and sought a reliable partner for the pre-clinical development and clinical trial material manufacture, which could possibly advance to commercial manufacture, if approved.

Cambrex has been successfully developing and manufacturing pre-clinical to commercial scale quantities of high potency APIs since 1998 and uses a data-driven Occupational Exposure Limit (OEL) assessment for compounds of unknown toxicity.

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