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?
In this webinar, we discussed the transfer of chromatographic methods that occurs at many stages in the development and production of a product. Here are a few questions that we received but did not have time to answer during the information-rich hour.
We’re all familiar with the adage, “Out with the old, in with the new,” but we probably tend to think of it as it applies to clothes for donation or past relationships, and maybe not… Read more >
The drug development process requires pharmacokinetic (PK) analysis to be performed as part of safety and efficacy studies in both preclinical species and human subjects. For high-sensitivity bioanalysis, liquid chromatography (LC) coupled to a triple… Read more >
As regulators focus in on the critical quality attributes of biotherapeutics, what can biopharmaceutical labs in late development or QC do to increase confidence in their bioseparations – other than to run more assays?
The thought of transferring established high performance liquid chromatography (HPLC) methods onto a another vendor’s LC, or a new platform like UHPLC/UPLC, may cause a bit of anxiety for those that may be unaware of… Read more >