Reducing Analytical Method Steps For Accelerated Product

By Stephan O. Krause, AstraZeneca Biologics

With an increasing number of products being considered for accelerated development, both the industry and regulators are looking for ways to safely hasten product development and approval times to ensure availability of innovative and low-cost drugs for patients. The development and validation of test methods during the regular product development lifecycle is a challenge. Not surprisingly, an accelerated timeline magnifies this challenge. Many developers struggle with bridging early-stage, fit-for-use test methods with the validated late-stage methods needed for process performance qualification (PPQ)/validation, routine production and post-approval requirements.