David C. Harmes

TL;DR: The analysis of a commercial rituximab sample shows that online sLC×LC-TOF-MS can be used to rapidly characterize mAb samples, yielding the identification of numerous variants, based on the analysis of intact, partially digested, and digested/reduced m Ab samples.

TL;DR: This study demonstrates the use of comprehensive 2D-LC separations involving cation-exchange (CEX) and reversed-phase (RP) separations in the first and second dimensions to compare 3 reference/biosimilar pairs of monoclonal antibodies that cover a range of similarity/disimilarity in a middle-up approach.

TL;DR: It is demonstrated that LCxLC is sufficiently sensitive to be useful in the pharmaceutical context where in general impurities present at 0.05 % (relative to the API concentration) should be quantified.

TL;DR: The ability to combine hydrophilic interaction and RP separations in an online comprehensive 2D separation coupled with high resolution MS detection (HILIC × RP-HRMS) is demonstrated and active solvent modulation (ASM) is critical for coupling these two separation modes, because it mitigates the otherwise serious negative impact of the acetonitrile-rich HILIC mobile phase on the second dimension RP separation.

TL;DR: This paper develops a sLC × LC method using multi-wavelength ultraviolet absorbance detection for the quantitative analysis of six target furanocoumarin compounds in extracts of celery, parsley, and parsnips and demonstrates the ability to perform the processes of 1D sampling and 2D separation in parallel.