caa a22 4500 445802715 CHVBK 20180317145146.0 cr unu---uuuuu 170323e20110601xx s 000 0 eng 10.1007/s10337-011-2017-3 doi (NATIONALLICENCE)springer-10.1007/s10337-011-2017-3 Intercompany Study to Evaluate the Robustness of Capillary Isoelectric Focusing Technology for the Analysis of Monoclonal Antibodies [Elektronische Daten] [Oscar Salas-Solano, Kunnel Babu, SungAe Park, Xinfeng Zhang, Li Zhang, Zoran Sosic, Boris Boumajny, Ming Zeng, Kuang-Chuan Cheng, Angelia Reed-Bogan, Stacey Cummins-Bitz, David Michels, Monica Parker, Paulina Bonasia, Mingfang Hong, Steven Cook, Margaret Ruesch, David Lamb, Dora Bolyan, Steffen Kiessig, Darren Allender, Brian Nunnally] Interlaboratory comparisons are essential to bringing emerging technologies into biopharmaceutical industry practice and regulatory acceptance. As a result, an international team including 12 laboratories from 10 independent biopharmaceutical companies in the United States and Switzerland was formed to evaluate the precision and robustness of capillary isoelectric focusing (CIEF) to assess the charge heterogeneity of monoclonal antibodies. The different laboratories determined the apparent pI and the relative distribution of the charge isoforms of a representative monoclonal antibody (rMAb) sample using the same CIEF method. Statistical evaluation of the data was performed to determine within and between-laboratory consistencies and outlying information. The apparent pI data generated for each charge variant peak showed very good precision between laboratories with percentage of RSD values of ≤0.5%. Similarly, the percentage of RSD for the rMAb charge variants percent peak area values are ≤4.4% across different laboratories with different analysts using different lots of ampholytes and multiple instruments. Taken together, these results validate the appropriate use of CIEF in the biopharmaceutical industry in support of regulatory submissions. Springer-Verlag, 2011 Capillary electrophoresis nationallicence Interlaboratory collaboration nationallicence Biopharmaceutical analysis nationallicence CIEF nationallicence Salas-Solano Oscar Analytical Biochemistry Department, Seattle Genetics Inc., 21823 30th Drive SE, 98021, Bothell, WA, USA aut Babu Kunnel Analytical Development and Testing, Bristol Myers Squibb, 311 Pennington Rocky Hill Road, 08534, Pennington, NJ, USA aut Park SungAe Formulation and Analytical Resource Group, Amgen Inc., One Amgen Center Dr. MS 8-1-C, 91320, Thousand Oaks, CA, USA aut Zhang Xinfeng Process and Product Engineering, Amgen Inc., 6701 Kaiser Drive, 94555, Fremont, CA, USA aut Zhang Li Process and Product Engineering, Amgen Inc., 6701 Kaiser Drive, 94555, Fremont, CA, USA aut Sosic Zoran Analytical Development, Biogen Idec, 14 Cambridge Center, MA 02142, Cambridge, USA aut Boumajny Boris Analytical Development, Biogen Idec, 14 Cambridge Center, MA 02142, Cambridge, USA aut Zeng Ming BPPD Analytical Development, Bristol Myers Squibb, 08534, Hopewell, NJ, USA aut Cheng Kuang-Chuan Biologics Third Party Manufacturing, Bristol Myers Squibb, 6000 Thompson Road, 13057, East Syracuse, NY, USA aut Reed-Bogan Angelia Bioproduct Pharmaceutical Research and Development, Eli Lilly and Company, 1400 West Raymond St., 46285, Indianapolis, IN, USA aut Cummins-Bitz Stacey Biosynthetic Technical Excellence Quality Control, Eli Lilly and Company, Drop code 5823, 46285, Indianapolis, IN, USA aut Michels David Protein Analytical Chemistry Department, Genentech, Inc., 1 DNA Way, 94080, South San Francisco, CA, USA aut Parker Monica Protein Analytical Chemistry Department, Genentech, Inc., 1 DNA Way, 94080, South San Francisco, CA, USA aut Bonasia Paulina Quality Control Technical Services, Genzyme, 45 New York Ave, 01701, Framingham, MA, USA aut Hong Mingfang Pharmaceutical Development and Manufacturing Sciences, Johnson and Johnson, 145 King of Prussia Rd, 19087, Radnor, PA, USA aut Cook Steven Analytical Research and Development, Global Biologics, Pfizer Global Research and Development, Pfizer, 700 Chesterfield Parkway West, 63017, Chesterfield, MO, USA aut Ruesch Margaret Analytical Research and Development, Global Biologics, Pfizer Global Research and Development, Pfizer, 700 Chesterfield Parkway West, 63017, Chesterfield, MO, USA aut Lamb David Analytical Process Technologies, Sanofi Pasteur, Discovery Drive, 18370, Swiftwater, PA, USA aut Bolyan Dora Protein Analytics Development, Solvias AG, WKL-127.2.36 Klybeckstr. 191, 4002, Basel, Switzerland aut Kiessig Steffen Pharma Technical Development Europe (Biologics) Analytics, F. Hoffmann-La Roche Ltd, Building 64/Room 204, 4070, Basel, Switzerland aut Allender Darren Analytical Biochemistry Department, Seattle Genetics Inc., 21823 30th Drive SE, 98021, Bothell, WA, USA aut Nunnally Brian Pfizer Global Manufacturing, Pfizer, 4300 Oak Park, 27330, Sanford, NC, USA aut Chromatographia Springer-Verlag 73/11-12(2011-06-01), 1137-1144 0009-5893 73:11-12<1137 2011 73 10337 https://doi.org/10.1007/s10337-011-2017-3 text/html Onlinezugriff via DOI 1 research-article jats NATIONALLICENCE 856 40 https://doi.org/10.1007/s10337-011-2017-3 text/html Onlinezugriff via DOI NATIONALLICENCE 700 1- Salas-Solano Oscar Analytical Biochemistry Department, Seattle Genetics Inc., 21823 30th Drive SE, 98021, Bothell, WA, USA aut NATIONALLICENCE 700 1- Babu Kunnel Analytical Development and Testing, Bristol Myers Squibb, 311 Pennington Rocky Hill Road, 08534, Pennington, NJ, USA aut NATIONALLICENCE 700 1- Park SungAe Formulation and Analytical Resource Group, Amgen Inc., One Amgen Center Dr. MS 8-1-C, 91320, Thousand Oaks, CA, USA aut NATIONALLICENCE 700 1- Zhang Xinfeng Process and Product Engineering, Amgen Inc., 6701 Kaiser Drive, 94555, Fremont, CA, USA aut NATIONALLICENCE 700 1- Zhang Li Process and Product Engineering, Amgen Inc., 6701 Kaiser Drive, 94555, Fremont, CA, USA aut NATIONALLICENCE 700 1- Sosic Zoran Analytical Development, Biogen Idec, 14 Cambridge Center, MA 02142, Cambridge, USA aut NATIONALLICENCE 700 1- Boumajny Boris Analytical Development, Biogen Idec, 14 Cambridge Center, MA 02142, Cambridge, USA aut NATIONALLICENCE 700 1- Zeng Ming BPPD Analytical Development, Bristol Myers Squibb, 08534, Hopewell, NJ, USA aut NATIONALLICENCE 700 1- Cheng Kuang-Chuan Biologics Third Party Manufacturing, Bristol Myers Squibb, 6000 Thompson Road, 13057, East Syracuse, NY, USA aut NATIONALLICENCE 700 1- Reed-Bogan Angelia Bioproduct Pharmaceutical Research and Development, Eli Lilly and Company, 1400 West Raymond St., 46285, Indianapolis, IN, USA aut NATIONALLICENCE 700 1- Cummins-Bitz Stacey Biosynthetic Technical Excellence Quality Control, Eli Lilly and Company, Drop code 5823, 46285, Indianapolis, IN, USA aut NATIONALLICENCE 700 1- Michels David Protein Analytical Chemistry Department, Genentech, Inc., 1 DNA Way, 94080, South San Francisco, CA, USA aut NATIONALLICENCE 700 1- Parker Monica Protein Analytical Chemistry Department, Genentech, Inc., 1 DNA Way, 94080, South San Francisco, CA, USA aut NATIONALLICENCE 700 1- Bonasia Paulina Quality Control Technical Services, Genzyme, 45 New York Ave, 01701, Framingham, MA, USA aut NATIONALLICENCE 700 1- Hong Mingfang Pharmaceutical Development and Manufacturing Sciences, Johnson and Johnson, 145 King of Prussia Rd, 19087, Radnor, PA, USA aut NATIONALLICENCE 700 1- Cook Steven Analytical Research and Development, Global Biologics, Pfizer Global Research and Development, Pfizer, 700 Chesterfield Parkway West, 63017, Chesterfield, MO, USA aut NATIONALLICENCE 700 1- Ruesch Margaret Analytical Research and Development, Global Biologics, Pfizer Global Research and Development, Pfizer, 700 Chesterfield Parkway West, 63017, Chesterfield, MO, USA aut NATIONALLICENCE 700 1- Lamb David Analytical Process Technologies, Sanofi Pasteur, Discovery Drive, 18370, Swiftwater, PA, USA aut NATIONALLICENCE 700 1- Bolyan Dora Protein Analytics Development, Solvias AG, WKL-127.2.36 Klybeckstr. 191, 4002, Basel, Switzerland aut NATIONALLICENCE 700 1- Kiessig Steffen Pharma Technical Development Europe (Biologics) Analytics, F. Hoffmann-La Roche Ltd, Building 64/Room 204, 4070, Basel, Switzerland aut NATIONALLICENCE 700 1- Allender Darren Analytical Biochemistry Department, Seattle Genetics Inc., 21823 30th Drive SE, 98021, Bothell, WA, USA aut NATIONALLICENCE 700 1- Nunnally Brian Pfizer Global Manufacturing, Pfizer, 4300 Oak Park, 27330, Sanford, NC, USA aut NATIONALLICENCE 773 0- Chromatographia Springer-Verlag 73/11-12(2011-06-01), 1137-1144 0009-5893 73:11-12<1137 2011 73 10337 Metadata rights reserved Springer special CC-BY-NC licence nationallicence BK010053 XK010053 XK010000 NATIONALLICENCE NATIONALLICENCE NL-springer