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Pure and Simplified

The biopharmaceutical industry is making significant progress towards more productive manufacture of monoclonal antibodies (mAbs). Driving this evolution is the need for reduced product change-over time, improved quality via increased robustness and reliability, and accelerated production and product release.

A key strategy for delivering higher productivity and enabling more flexible manufacturing processes is the adoption of single-use technologies. As the industry pursues and adopts singleuse approaches, conventional purification technologies present limitations. Resin-based columns are often oversized to match new achievements in upstream productivity, and this translates into a larger footprint that requires more media, increased maintenance, and quality assurance and control. High capital and operating expenses require amortisation over many batches to achieve cost efficiency. While costs can be reduced via economies of scale for large volume products, this is not the direction in which the industry is heading.

Mochao Zhao at Merck (October 2019)

Keywords: Purification, Chromatography, Separation, Biopharma, Monoclonal antibodies, Merck, Samedan ltd

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