Article | October 21, 2020

A Streamlined Approach To Analytical Method Development And Implementation

By Heike Monange

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The development and implementation of analytical methods are essential for success at all phases of a molecule’s journey, from pre-clinical development, to clinical manufacturing and ultimately, commercialization.

Critical Success Factors for your Analytical Program

  • #1 Invest time and resources from the earliest stages of product characterization to identify the critical quality attributes and establish analytical methods
  • #2 Follow the quality attributes throughout the process to understand clearance of impurities and behavior of the molecule
  • #3 Begin development of a cell-based assay early to ensure an activity method is available at the start of development
  • #4 Remember that process development can be accelerated with a robust analytical panel

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