Article | December 6, 2013

Enabling Technology Can be Critical To Timely CMO Delivery

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James Schwindeman

APIs that are advancing from discovery into the clinic are increasingly complex, and the chemistry and/or biology necessary to manufacture these compounds requires increasing sophistication. The selection of a CMO (Contract Manufacturing Organization) is the crucial decision in the life of any outsourced project. Therefore, it is imperative to select a CMO that can produce the desired compound, to the desired specifications, in the desired timeframe. One key consideration in the selection process is the technology available in the toolbox of the CMO. As the majority of new APIs under development are still small molecules, this article focuses on the required “classical” chemical capabilities for constructing such molecules. Some selected technologies include: chemocatalytic and biocatalytic transformations, transition metal couplings, high pressure chemistry, cryogenic technologies, hazardous reactions and chromatographic technologies like Simulated Moving Bed. Consideration should be given to the ability of the CMO to practice the required technologies at all scales - from laboratory to pilot plant to commercial production equipment.

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