Aldevron Breakthrough Blog: Analytics

A Maturing Market

Expectations, oversight and transparency

From the early days of therapeutics development, a common refrain has been that GMP manufacturing takes longer and costs more than expected. This can be traced back to when programs often started in academic laboratories, which then needed substantial analytical and process development as a program moved towards clinical stages.

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Expanding an Analytical Framework

Increased expectations, increased accountability

Rapid evolution. In short, that’s what we’re seeing in the method development and assay life cycle field. The concepts have been around for quite some time, but now with updated and new guidance for analytical life cycle and analytical method development, we’re seeing a more dynamic period emerging in the space. This includes increased expectations for analytical method development and increased accountability for reporting development data.

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