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Intercompany Study to Evaluate the Robustness of Capillary Isoelectric Focusing Technology for the Analysis of Monoclonal Antibodies |
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| Authors: | Oscar Salas-Solano Kunnel Babu SungAe Suhr Park Xinfeng Zhang Li Zhang Zoran Sosic Boris Boumajny Ming Zeng Kuang-Chuan Cheng Angelia Reed-Bogan Stacey Cummins-Bitz David A. Michels Monica Parker Paulina Bonasia Mingfang Hong Steven Cook Margaret Ruesch David Lamb Dora Bolyan Steffen Kiessig Darren Allender Brian Nunnally |
| Affiliation: | 1. Analytical Biochemistry Department, Seattle Genetics Inc., 21823 30th Drive SE, Bothell, WA, 98021, USA 2. Analytical Development and Testing, Bristol Myers Squibb, 311 Pennington Rocky Hill Road, Pennington, NJ, 08534, USA 3. Formulation and Analytical Resource Group, Amgen Inc., One Amgen Center Dr. MS 8-1-C, Thousand Oaks, CA, 91320, USA 4. Process and Product Engineering, Amgen Inc., 6701 Kaiser Drive, Fremont, CA, 94555, USA 5. Analytical Development, Biogen Idec, 14 Cambridge Center, Cambridge, MA 02142, USA 6. BPPD Analytical Development, Bristol Myers Squibb, Hopewell, NJ, 08534, USA 7. Biologics Third Party Manufacturing, Bristol Myers Squibb, 6000 Thompson Road, East Syracuse, NY, 13057, USA 8. Bioproduct Pharmaceutical Research and Development, Eli Lilly and Company, 1400 West Raymond St., Indianapolis, IN, 46285, USA 9. Biosynthetic Technical Excellence Quality Control, Eli Lilly and Company, Drop code 5823, Indianapolis, IN, 46285, USA 10. Protein Analytical Chemistry Department, Genentech, Inc., 1 DNA Way, South San Francisco, CA, 94080, USA 11. Quality Control Technical Services, Genzyme, 45 New York Ave, Framingham, MA, 01701, USA 12. Pharmaceutical Development and Manufacturing Sciences, Johnson and Johnson, 145 King of Prussia Rd, Radnor, PA, 19087, USA 13. Analytical Research and Development, Global Biologics, Pfizer Global Research and Development, Pfizer, 700 Chesterfield Parkway West, Chesterfield, MO, 63017, USA 14. Analytical Process Technologies, Sanofi Pasteur, Discovery Drive, Swiftwater, PA, 18370, USA 15. Protein Analytics Development, Solvias AG, WKL-127.2.36 Klybeckstr. 191, 4002, Basel, Switzerland 16. Pharma Technical Development Europe (Biologics) Analytics, F. Hoffmann-La Roche Ltd, Building 64/Room 204, 4070, Basel, Switzerland 17. Pfizer Global Manufacturing, Pfizer, 4300 Oak Park, Sanford, NC, 27330, USA |
| Abstract: | 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. |
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