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Development of a 3‐step straight‐through purification strategy combining membrane adsorbers and resins
Author(s) -
Hughson Michael D.,
Cruz Thayana A.,
Carvalho Rimenys J.,
Castilho Leda R.
Publication year - 2017
Publication title -
biotechnology progress
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.572
H-Index - 129
eISSN - 1520-6033
pISSN - 8756-7938
DOI - 10.1002/btpr.2501
Subject(s) - downstream processing , chinese hamster ovary cell , chromatography , chemistry , affinity chromatography , membrane , biopharmaceutical , process development , process engineering , biochemistry , microbiology and biotechnology , biology , engineering , receptor , enzyme
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