The Purification Insights Blog

What are the benefits of introducing multimodal ion exchange chromatography as a guard column and could they include a significant increase in mAb purity? This article presents a study in which two protein A affinity chromatography resins were compared to see whether the introduction of a guard column could improve mAb purity and to discover which of the protein A resins produced the best results.

In short, an efficient protein A resin is one that will not only help you purify your monoclonal antibody (mAb), but also enable you to achieve good process economy. But what are the characteristics of such a resin and how can it improve your processes? Here are the characteristics to look for when selecting a resin for your mAb purification.

In 2015, the monoclonal antibodies (mAbs) market was estimated to be USD 85,4 billion and predicted to reach approximately USD 130 billion in 2023^[1]. However, new research points at a much higher number. According to Zion Market Research, the global mAbs market will reach USD 219 billion by the end of 2023^[2]. The market growth was much higher than expected only a few years ago, and even this number might be surpassed as we approach 2023.

Monoclonal antibodies, mAbs, form a well-established, technologically advanced segment of the pharmaceutical industry offering hope for large groups of patients who have difficult-to-treat cancers, rheumatoid arthritis or other serious diseases. More than 50 percent of the biopharmaceuticals on the market today are mAbs and more mAb therapies are in the pipeline ^[1]. The quality requirements of mAbs are very stringent, leading to high costs of production as well as high treatment costs. In this article we will take a look at mAb purity and give an overview of two strategies that can be used to develop a suitably pure protein – In-process control and Quality by Design.