Waters recently surveyed 100 method developers from innovator and generic pharmaceutical companies to better understand their existing challenges and views on Method Lifecycle Management (MLCM). We’ll share with you the top questions and findings from our survey results.
“Assuming continuous improvement is a worthy goal, there is every reason to improve validated chromatographic methods if you’re working with the right instrument technology,” says Eric Grumbach of Waters. See what that means for developing and transferring methods for biologic drugs.
One scientist at a major global pharma company estimated that an analytical method could see up to 100 transfers in its lifetime. Increasingly, such transfers will take place across geographic borders. How ready are you to mobilize your methods?
Is your analytical method bound for the lab down the hall, or the lab halfway around the world? If you’re an analytical or QC scientist, get ready for more method transfers between organizations. We explore the complexities of analytical method transfer in part 2 of our ongoing series.
There’s a new analytical testing landscape taking shape, and it’s having a big effect on how we develop, transfer, and update methods. Data quality and business efficiency are both at stake. Are you ready?
