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Development of a 3‐step straight‐through purification strategy combining membrane adsorbers and resins

Abstract

The pressures to efficiently produce complex biopharmaceuticals at reduced costs are driving the development of novel techniques, such as in downstream processing with straight‐through processing (STP). This method involves directly and sequentially purifying a particular target with minimal holding steps. This work developed and compared 6 different 3‐step STP strategies, combining membrane adsorbers, monoliths and resins, to purify a large, complex and labile glycoprotein from Chinese hamster ovary (CHO) cell culture supernatant. The best performing pathway was cation exchange chromatography to hydrophobic interaction chromatography to affinity chromatography with an overall product recovery of up to 88% across the process and significant clearance of DNA and protein impurities. This work establishes a platform and considerations for the development of straight‐through processing of biopharmaceutical products and highlights its suitability for integration with single‐use technologies and continuous production methods. This article is protected by copyright. All rights reserved.

Authors:   Michael D. Hughson, Thayana A. Cruz, Rimenys J. Carvalho, Leda R. Castilho
Journal:   Biotechnology Progress
Year:   2017
Pages:   n/a
DOI:   10.1002/btpr.2501
Publication date:   27-May-2017
Facts, background information, dossiers
  • resins
  • membrane adsorbers
  • impurities
  • DNA
  • copyright
  • continuous production
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