Robustness of iCIEF methodology for the analysis of monoclonal antibodies: An interlaboratory study

Journal of Separation Science

Volumn 35, Issue 22, 2012, Pages 3124-3129

  Salas Solano, Oscar ^a   Kennel, Babu ^b   Park, Sungae Suhr ^c   Roby, Kelly ^d   Sosic, Zoran ^e   Boumajny, Boris ^e   Free, Sarah ^e   Reed Bogan, Angelia ^f   Michels, David ^g   McElroy, Will ^g   Bonasia, Pauline ^h   Hong, Mingfang ⁱ   He, Xiaoping ^j   Ruesch, Margaret ^j   Moffatt, Frank ^k   Kiessig, Steffen ^l   Nunnally, Brian ^e  

^a SEATTLE GENETICS INC   (United States)

^b BRISTOL MYERS SQUIBB COMPANY   (United States)

^c AMGEN INC   (United States)

^d BioPharma Solutions   (United States)

^e BIOGEN   (United States)

^f ELI LILLY AND COMPANY   (United States)

^g GENENTECH INC   (United States)

^h Genzyme   (United States)

ⁱ Pharmaceutical Development and Manufacturing Sciences   (United States)

^j PFIZER GLOBAL RESEARCH AND DEVELOPMENT   (United States)

^k SOLVIAS AG   (Switzerland)

^l F HOFFMANN LA ROCHE LTD   (Switzerland)

more..

Author keywords

Biopharmaceutical analysis; Capillary electrophoresis; CIEF; Imaged capillary isoelectric focusing; Interlaboratory

Indexed keywords

AMPHOLYTES; BIOPHARMACEUTICAL ANALYSIS; BIOPHARMACEUTICAL INDUSTRY; CAPILLARY ISOELECTRIC FOCUSING; CHARGE HETEROGENEITY; CIEF; IMAGED CAPILLARY ISOELECTRIC-FOCUSING; INTERLABORATORY; INTERLABORATORY STUDIES; INTERNATIONAL TEAM; ISOFORMS; MULTIPLE INSTRUMENTS; PEAK AREA; PROCESS DEVELOPMENT; REGULATORY SUBMISSIONS; STATISTICAL EVALUATION; SWITZERLAND; THERAPEUTIC ANTIBODIES; THERAPEUTIC MONOCLONAL ANTIBODIES; VARIANT PEAK;

CAPILLARY ELECTROPHORESIS; MONOCLONAL ANTIBODIES; SURFACE PLASMON RESONANCE;

LABORATORIES;

AMPHOLYTE; MONOCLONAL ANTIBODY;

ACCURACY; ARTICLE; CAPILLARY ISOELECTRIC FOCUSING; DRUG INDUSTRY; INFORMATION; LABORATORY; METHODOLOGY; PRIORITY JOURNAL; QUANTITATIVE ANALYSIS; SWITZERLAND; UNITED STATES;

ANTIBODIES, MONOCLONAL; ELECTROPHORESIS, CAPILLARY; HUMANS; ISOELECTRIC FOCUSING; LABORATORIES; PROTEIN ISOFORMS; SWITZERLAND;

EID: 84870001724     PISSN: 16159306     EISSN: 16159314     Source Type: Journal    
DOI: 10.1002/jssc.201200633     Document Type: Article

References (8)

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