| Purification of an Fc-fusion biologic: clearance of multiple product related impurities by hydrophobic interaction chromatography. | |
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MedLine Citation:
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PMID: 17692855 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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An hydrophobic interaction chromatography step was developed for the large-scale production of an Fc-fusion biologic. Two abundant product-related impurities were separated from the active monomer using a Butyl resin and a simple step-wash and step-elution strategy. Capacity and resolution of the HIC step was optimal when sodium sulfate was employed as the lyotropic salt and pore size of the Butyl resin was 750A. Factorial analysis identified critical parameters for the Butyl chromatography and an operating window capable of delivering high product quality and yield over a broad column loading range. |
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Authors:
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David R H Evans; Richard P Macniven; Marisa Labanca; Joshua Walker; Stephen M Notarnicola |
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Publication Detail:
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Type: Evaluation Studies; Journal Article Date: 2007-07-28 |
Journal Detail:
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Title: Journal of chromatography. A Volume: 1177 ISSN: 0021-9673 ISO Abbreviation: J Chromatogr A Publication Date: 2008 Jan |
Date Detail:
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Created Date: 2007-12-31 Completed Date: 2008-03-06 Revised Date: 2009-01-15 |
Medline Journal Info:
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Nlm Unique ID: 9318488 Medline TA: J Chromatogr A Country: Netherlands |
Other Details:
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Languages: eng Pagination: 265-71 Citation Subset: IM |
Affiliation:
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Biogen Idec Corporation, Bioprocess Development, 14 Cambridge Center, Cambridge, MA 02142, USA. david.evans@biogenidec.com |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Animals CHO Cells / metabolism Chromatography, Affinity / methods Chromatography, Liquid / instrumentation, methods* Cricetinae Cricetulus Culture Media, Conditioned / chemistry Hydrophobicity* Immunoglobulin Fc Fragments / chemistry, isolation & purification* Recombinant Fusion Proteins / chemistry, isolation & purification* Reproducibility of Results Sensitivity and Specificity Sepharose / analogs & derivatives, chemistry Staphylococcal Protein A / chemistry |
| Chemical | |
Reg. No./Substance:
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0/Culture Media, Conditioned; 0/Immunoglobulin Fc Fragments; 0/Recombinant Fusion Proteins; 0/Staphylococcal Protein A; 71822-39-4/phenyl-sepharose; 72980-05-3/butylagarose; 9012-36-6/Sepharose |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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