| Performance of a membrane adsorber for trace impurity removal in biotechnology manufacturing. | |
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MedLine Citation:
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PMID: 16007984 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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Membrane adsorbers provide an attractive alternative to traditional bead-based chromatography columns used to remove trace impurities in downstream applications. A linearly scalable novel membrane adsorber family designed for the efficient removal of trace impurities from biotherapeutics, are capable of reproducibly achieving greater than 4 log removal of mammalian viruses, 3 log removal of endotoxin and DNA, and greater than 1 log removal of host cell protein. Single use, disposable membrane adsorbers eliminate the need for costly and time consuming column packing and cleaning validation associated with bead-based chromatography systems, and minimize the required number and volume of buffers. A membrane adsorber step reduces process time, floor space, buffer usage, labor cost, and improves manufacturing flexibility. This "process compression" effect is commonly associated with reducing the number of processing steps. The rigid microporous structure of the membrane layers allows for high process flux operation and uniform bed consistency at all processing scales. |
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Authors:
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Michael Phillips; Jason Cormier; Jennifer Ferrence; Chris Dowd; Robert Kiss; Herbert Lutz; Jeffrey Carter |
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Publication Detail:
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Type: Journal Article |
Journal Detail:
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Title: Journal of chromatography. A Volume: 1078 ISSN: 0021-9673 ISO Abbreviation: J Chromatogr A Publication Date: 2005 Jun |
Date Detail:
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Created Date: 2005-07-12 Completed Date: 2005-09-08 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: 74-82 Citation Subset: IM |
Affiliation:
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Biopharmaceutical R&D Division, Millipore Corp., 32 Wiggins Ave, Bedford, MA 01730, USA. |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Adsorption Animals Antibodies, Monoclonal Bacterial Proteins / isolation & purification Bacteriophage phi 6 / isolation & purification Bacteriophage phi X 174 / isolation & purification Bacteriophages / isolation & purification* Biotechnology / methods Chromatography, Ion Exchange / instrumentation, methods* DNA / isolation & purification* Endotoxins / isolation & purification* Escherichia coli / virology Humans Hydrogen-Ion Concentration Leukemia Virus, Murine / isolation & purification Membranes, Artificial* Mice Minute virus of mice / isolation & purification Osmolar Concentration Pilot Projects Pseudomonas pseudoalcaligenes / virology Reproducibility of Results Simian virus 40 / isolation & purification |
| Chemical | |
Reg. No./Substance:
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0/Antibodies, Monoclonal; 0/Bacterial Proteins; 0/Endotoxins; 0/Membranes, Artificial; 9007-49-2/DNA |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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