Development of a 3‐step straight‐through purification strategy combining membrane adsorbers and resins. (19th June 2017)

• Record Type: Journal Article
• Authors: Hughson, Michael D.; Cruz, Thayana A.; Carvalho, Rimenys J.; Castilho, Leda R.
• Is Part Of: Biotechnology progress. Volume 33:Number 4(2017)
• Page Start: 931
• Page End: 940
• Publication Date: 2017-06-19
• Subjects: process development -- protein liquid chromatography -- membrane adsorbers -- integrated processing -- straight‐through processing -- CHO derived biopharmaceutical glycoprotein; Biotechnology -- Periodicals; Food industry and trade -- Periodicals; Bioengineering -- Periodicals; 660.6
• DOI: 10.1002/btpr.2501
• Languages: English
• ISSNs: 8756-7938

Abstract

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 six different 3‐step STP strategies, combining membrane adsorbers, monoliths, and resins, to purify a large, complex, and labile glycoprotein from Chinese hamster ovary 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 STP of biopharmaceutical products and highlights its suitability for integration with single‐use technologies and continuous production methods. © 2017 American Institute of Chemical Engineers Biotechnol. Prog., 33:931–940, 2017