DryLab and Empower: a successful combination for the optimisation of mAb subunit analysis

Pharma in MOTION event (Waters Corporation)

The analysis of monoclonal antibodies at the subunit level, with UV or MS detection, is a valuable tool, either during process development or for characterisation studies. The separation is commonly performed using reversed-phase chromatography, but hydrophilic interaction liquid chromatography (HILIC) can also be used to separate glycosylated species. The optimisation of these separations can be tricky, as small modifications of the experimental conditions can have a huge impact on the resolution.

Arnaud Delobel, R&D Director at Quality Assistance, recently presented a case study on the separation of an IdeS-digested monoclonal antibody (nivolumab) by RP and HILIC. The use of DryLab with Empower automation module allowed us to develop quick and robust methods in a very short timeframe.

PRESENTATION OVERVIEW

Separation of mAb subunits by RP and HILIC
Modeling of U(H)PLC separations using DryLab
DryLab's Empower™ Automation Module