A Streamlined Approach To Analytical Method Development And Implementation

By Heike Monange

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