Methods evolve as project evolves: fit-for-purpose evaluation, analytical target profile establishment, method change in response of vendor changes, method bridging at different development stages, continuous method optimization and trending. Strategy /or guideline of method life cycle management is important to help streamline product development, to provide quality measurements, and to sustain post licensure testing support. We’ll present some case studies in establishing method life cycle management.

Analytical method evolution during biological product life cycle

251st National Meeting (2016)

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