Pharma in MOTION event (Waters Corporation)

Quality Assistance participates to Waters’ Pharma in MOTION event.

The goal of this four-day virtual edition is to discuss the unique challenges the pharma industry faces and share potential problem-solving solutions.

Arnaud Delobel will be one of the leading experts for this event. We will be sharing our latest developments from the areas of protein and peptide bioanalysis. Related method development approaches will be presented.

PRESENTATION OVERVIEW
Arnaud Delobel, R&D Director at Quality Assistance

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

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. We present 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.

About Quality Assistance

With more than 35 years’ experience, Quality Assistance has become a leader in analytical sciences and holds a unique position on the market with all its laboratories on one site and 220 highly qualified professionals.

We assist our clients from candidate selection, through non-clinical and clinical studies, to marketing authorisation, using our state-of-the-art, product-dedicated expertise in analytical sciences. For each customer and each project, we design customised solutions, define analytical protocols, develop and validate specific new analytical methods and perform characterisation, stability, pharmacokinetic, biomarker and immunogenicity studies as well as batch release testing, in order to evaluate the Quality, Safety and Efficacy of the given drugs.

Contact us to discuss your outsourcing needs and challenges.

We are here to accelerate the development and marketing of your products.