Introduction

The purification of ADCs presents significant challenges in maintaining product safety and stability due to their delicate structure. On a lab-scale, ADCs are conventionally purified using size exclusion chromatography (SEC), which is effective but time-consuming, and is limited by volume constraints. Moreover, this method necessitates subsequent formulation through dead-end filtration (DEF) using centrifugal devices, adding to the labor-intensive nature of the process.

Alternatively, tangential flow filtration (TFF) integrates ADC purification and formulation into a single step, ensuring faster and scalable processing. However, traditional TFF systems have large hold-up volumes, making them unsuitable for lab-scale ADC purification. The µPulse^® - TFF system by Formulatrix addresses this limitation with a miniaturized design by combining TFF with microfluidic pumping technology on a filter chip. This footprint reduces the hold-up volume to 0.65 mL, which is up to 100% recoverable. Additionally, weight-based sensing ensures effective control over the final volume, making the µPulse a walk-away system. This study demonstrates how the µPulse provides a single-step, automated solution for ADC purification, compared to SEC+DEF approach.