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A Series of Collaborations between Various Pharmaceutical Companies and Regulatory Authorities Concerning the Analysis of Biomolecules Using Capillary Electrophoresis: Additional Instruments/Buffer |
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| Authors: | Brian Nunnally SungAe Park Ketaki Patel Mingfang Hong Xinfeng Zhang Shao-Xiong Wang Brenda Rener Angelia Reed-Bogan Oscar Salas-Solano Wendy Lau Michel Girard Heather Carnegie Virginia Garcia-Cañas K. C. Cheng Ming Zeng Margaret Ruesch Ronald Frazier Claudia Jochheim Kshama Natarajan K. Michael Jessop Mansoor Saeed Frank Moffatt Seth Madren Serigne Thiam Kevin Altria |
| Affiliation: | 1. Vaccine Analytical Development, Wyeth Research, Wyeth, 4300 Oak Park, Sanford, NC, 27330, USA 2. Pharmaceutics Department, Amgen Inc, One Amgen Center Dr. MS 8-1-C, Thousand Oaks, CA, 91320, USA 3. Pharmaceutical Development, Centocor Research and Development Incorporation, 145 King of Prussia Road, Radnor, PA, 19087, USA 4. Analytical Development, Chiron Corporation (now Novartis Vaccines and Diagnostics, Inc.), 4560 Horton Street, Emeryville, CA, 94608, USA 5. Bioproduct Pharmaceutical Research and Development, Lilly Research Laboratories, Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, 46285, USA 6. Late-Stage Analytical Development, Genentech, Inc, 1 DNA Way, South San Francisco, CA, 94080, USA 7. Centre for Biologics Research, Health Canada, Banting Bldg., Tunney’s Pasture, K1A 0L2, Ottawa, ON, Canada 8. Analytical Development and Formulation Development, Medarex, Inc, 519 Route 173 West, Bloomsbury, NJ, 08804, USA 9. Analytical Research and Development, Global Biologics, Pfizer Global Research and Development, Pfizer, 700 Chesterfield Parkway West, Chesterfield, MO, 63017, USA 10. Protein Sciences, Pfizer Global Research and Development, Pfizer, 700 Chesterfield Parkway West, Chesterfield, MO, 63017, USA 11. Analytical Biochemistry and Formulations, Seattle Genetics Inc, 21823 30th Drive Southeast, Bothell, WA, 98021, USA 12. Syngenta Ltd, Jealotts Hill, Bracknell, Berkshire, RG42 6EY, UK 13. Pharmaceutical Development, GlaxoSmithKline, Third Avenue, Harlow, Essex, CM23 1DW, UK |
| Abstract: | An international project team (including members from US, Canada and UK) was formed from a number of interested biopharmaceutical companies and regulatory authorities to conduct a cross-organisation collaboration exercise. The results of the first comparison with eight different organisations that used instruments of the same equipment model, the same reagents, and the same methodology has been reported previously [1]. This report represents the addition of other instruments using a different run buffer. The relative migration times were different, as expected, prohibiting a direct comparison between companies. The within-organisation variability was low for both relative migration time (<0.34% RSD% for all companies save one) and the peak area (<5% RSD% for all companies save one) when measuring the purity of a representative IgG sample. The apparent molecular weight of bovine serum albumin was measured with good precision (less than 10% RSD% across all companies) to the theoretical value when all data is utilized (67.5 kDa compared to 66.4 kDa). For a representative IgG sample, the three main components, IgG Light Chain, IgG Non-glycosylated Heavy Chain, and IgG Heavy Chain, could not be separated, specifically the IgG Non-glycosylated Heavy Chain and IgG Heavy Chain. When the IgG Non-glycosylated Heavy Chain and IgG Heavy Chain were combined for all organisations, the fractional peak area for the IgG Light Chain and IgG Non-glycosylated Heavy Chain + IgG Heavy Chain peak also showed excellent agreement, with less than 7.5 and 3.5% RSD%, respectively. The value of this exercise is in demonstrating the reliability of CE for the determination of apparent size of biopharmaceutical proteins. This underpins the appropriate use of such CE data in support of regulatory submissions. |
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