The Purification Insights Blog

How pure is pure? Controlling your mAb purification process

Posted by The Bio-Works Team on Dec 12, 2018 8:53:58 AM

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.

 

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Topics: mAbs, Biopharmaceuticals

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