Outsourcing High Potency Product Manufacturing: Key Selection Criteria

Overview:

While highly potent compounds can have significant benefits in the treatment of certain medical conditions, they present substantial challenges to the pharmaceutical industry.

Many companies are choosing to outsource the manufacture of their highly potent compounds for strategic and/or economic reasons.

This white paper outlines some of the elements that should be considered by a sponsor pharmaceutical company when outsourcing secondary processing (i.e. dosage form transfer, scale-up and commercial manufacture) of a highly potent product.

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