Kieran O’Connor is Analytical Science and Technology senior chemist at SK biotek, Ireland, [email protected]. (formerly Bristol Myers Squibb)
Spectroscopic-based control methods were introduced as equivalent alternative methods, first to a gas chromatographic method to monitor an in-process solvent exchange step and second to a potentiometric titration method to release a process input material for drug substance manufacturing.
The primary impact of using the covalidation model is the expedited analytical method qualification of both the transferring and receiving laboratories.
February 2nd 2019
