MAb Quantitation Protein A HPLC vs Protein A Bio-Layer Interferometry

Introduction

There are currently 30 monoclonal antibodies approved by the FDA as biotherapeutic agents, representing the most rapidly growing class of new drugs.

Despite advances in downstream processing technology, affinity purification of monoclonal antibodies using Protein A chromatography is still the industry standard.

In order to use Protein A resin as productively as possible it is important to load the resin at close to its dynamic binding capacity (DBC). DBC is normally determined with small sorbent volumes before scaling up to the process level. Here we look at the effects of residence time and MAb concentration on Protein A dynamic binding capacity. The knowledge of DBC under these conditions allows us to scale our process robustly, while maintaining high resin productivity.

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