Successfully advancing biopharmaceutical drug candidates from early development to clinical trials, and eventually to commercialization, requires a systematic approach and in-depth consideration of analytical method development and validation needs. With development timelines continuing to shrink and impacting priorities, there is a growing risk that drug developers may give insufficient emphasis and attention to these analytical functions that are crucial to the life cycle of a biopharmaceutical product. Working with a contract development and manufacturing organization (CDMO) that has a legacy of experience developing biosimilars on the path to commercialization can ensure comprehensive product and process analysis using robust, fit-for-purpose methods in a compliant manner, all while supporting shortened timelines.

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