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

Morgane Lescut
Claire Butré
Arnaud Delobel

The development of liquid chromatography (LC) methods has long been done using a trial-and-error approach, also known as “one factor at a time” (OFAT). While this approach is the easiest to implement, it is both time-consuming and quite inefficient. Usually, this approach does not lead to the optimal method in terms of performance and robustness.

Retention modelling is the method of choice for LC method development:

  • There is no need to know the structure of the solutes to be separated.

  • The retention behaviour of common solutes, including proteins, is well known in many HPLC modes.

  • Prediction is based on well-established empirical models.

  • By running a few initial experiments (between 2 and 12), the separation can be predicted for any conditions.

  • Changes in conditions can be studied in silico (for example, change of column dimensions, flow rate, gradient time, etc.).

In this application note, we present the use of DryLab (Molnár Institute) interfaced with Empower 3 (Waters) for the development of LC methods applied to monoclonal antibody subunits.