Development and validation of immunoassays to quantify the half-antibody exchange of an IgG4 antibody, natalizumab (Tysabri ®) with endogenous IgG4

Journal of Pharmaceutical and Biomedical Analysis

Volumn 55, Issue 1, 2011, Pages 168-175

  Shapiro, Renée I ^a   Plavina, Tatiana ^a   Schlain, Brian R ^a   Pepinsky, R Blake ^a   Garber, Ellen A ^a   Jarpe, Matthew ^a,c   Hochman, Paula S ^a   Wehner, Nancy G ^b   Bard, Frederique ^b   Motter, Ruth ^b   Yednock, Ted A ^b   Taylor, Frederick R ^a  

^a BIOGEN   (United States)

^b ELAN PHARMACEUTICALS   (United States)

^c Acetylon Pharmaceuticals   (United States)

Author keywords

Bispecific; Fab arm exchange; Half antibody exchange; IgG4; Natalizumab; Validated assays

Indexed keywords

IMMUNOGLOBULIN G4; MONOCLONAL ANTIBODY; NATALIZUMAB;

ACCURACY; ANIMAL CELL; ARTICLE; CONTROLLED STUDY; DOSE RESPONSE; DRUG BLOOD LEVEL; FEMALE; HALF ANTIBODY EXCHANGE; IMMUNOASSAY; LIMIT OF DETECTION; NONHUMAN; PHARMACOLOGICAL PARAMETERS; PRIORITY JOURNAL; QUANTITATIVE ANALYSIS; RAT; SENSITIVITY AND SPECIFICITY; VALIDATION STUDY;

ALGORITHMS; ANIMALS; ANTIBODIES, BISPECIFIC; ANTIBODIES, MONOCLONAL; ANTIBODIES, MONOCLONAL, HUMANIZED; CROHN DISEASE; HUMANS; IMMUNOASSAY; IMMUNOGLOBULIN G; IMMUNOGLOBULIN VARIABLE REGION; INTEGRIN ALPHA4; LIMIT OF DETECTION; MULTIPLE SCLEROSIS; MUTANT PROTEINS; PROTEIN REFOLDING; RATS; RATS, SPRAGUE-DAWLEY; REPRODUCIBILITY OF RESULTS; TECHNOLOGY, PHARMACEUTICAL;

EID: 79951734387     PISSN: 07317085     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jpba.2011.01.006     Document Type: Article

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