Analysis of viral clearance unit operations for monoclonal antibodies

Biotechnology and Bioengineering

Volumn 106, Issue 2, 2010, Pages 238-246

  Miesegaes, George ^a   Lute, Scott ^a   Brorson, Kurt ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

Downstream processing; Therapeutic monoclonal antibody; Viral clearance

Indexed keywords

BIOTECHNOLOGY PRODUCTS; CRITICAL STEPS; DOWNSTREAM-PROCESSING; HISTORICAL ANALYSIS; ION EXCHANGE CHROMATOGRAPHY; LOG REDUCTION VALUES; PRODUCT INFORMATION; PROTEIN A; REGULATORY SUBMISSIONS; THERAPEUTIC MONOCLONAL ANTIBODIES; UNIT OPERATION; VIRAL CLEARANCE;

ALLERGIES; CHROMATOGRAPHIC ANALYSIS; FILTRATION; ION CHROMATOGRAPHY; ION EXCHANGE; PHASE TRANSITIONS; SURFACE PLASMON RESONANCE; VIRUSES;

MONOCLONAL ANTIBODIES;

MONOCLONAL ANTIBODY; PROTEIN A;

ARTICLE; CLEARANCE; DATA BASE; FOOD AND DRUG ADMINISTRATION; INFORMATION PROCESSING; ION EXCHANGE CHROMATOGRAPHY; NONHUMAN; PARVOVIRUS; PH; RETROVIRUS; VIRUS;

ANTIBODIES, MONOCLONAL; CELL CULTURE TECHNIQUES; DRUG CONTAMINATION; VIRUSES;

PARVOVIRUS;

EID: 77953045118     PISSN: 00063592     EISSN: 10970290     Source Type: Journal    
DOI: 10.1002/bit.22662     Document Type: Article

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