LCGC North America-01-01-2020

Click the title above to open the LCGC North America January 2020 issue, Volume 38, Number 1, in an interactive PDF format.

We return to the important topic of buffers, this time focusing on what happens when there is a mismatch between the mobile-phase buffer pH and the pH that the sample is buffered at.

Advanced separation and mass spectrometry methods enable comprehensive profiling of the inherent glycan heterogeneities of protein therapeutics. In particular, reversed-phase HPLC–based multiattribute methods (MAMs) provide a wealth of information, and other techniques, such as HILIC and CE-MS, also continue to evolve.

A look at how data integrity requirements and the focus of data integrity have changed over the past five years.

Drug substance development requires a complex range of analytical methods, presenting a challenge to analytical chemists to reliably transfer and execute these fit-for-purpose methods to external manufacturing sites. Here, we provide guidelines to follow, and share examples of realworld problems and the strategies used to remedy them.