BioPharma Compass 2.0 and the maXis II were used for the automated assessment of the NIST antibody using three complementary approaches, intact, subunit domain and bottom-up. This combination provided fast,  accurate and in-depth information for antibody analysis using a single software platform. BPC 2.0 was developed for maximum ease-of-use whilst retaining the experimental flexibility required by today’s biopharmaceutical  analytical laboratory. The software also supports 21 CFR Part 11 compliant work.

The particular advantages of the described approaches are:Intact mass: Fast screening for expected glycoforms including low abundant species such as the aglycan and early detection of antibody processing artefacts.Subunit domain: Accurate mass analysis of antibody subunits on the sub ppm level, glycoform quantitation and further localization of sequence deviations on the Fd, Fc/2 or LC domains (2).Bottom up: Near 100% sequence and fragment coverage for sequence validation from a single experiment.