A Series of Collaborations Between Various Pharmaceutical Companies and Regulatory Authorities Concerning the Analysis of Biomolecules Using Capillary Electrophoresis |
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| Authors: | B. Nunnally S. S. Park K. Patel M. Hong X. Zhang S. -X. Wang B. Rener A. Reed-Bogan O. Salas-Solano W. Lau M. Girard H. Carnegie V. Garcia-Cañas K. C. Cheng M. Zeng M. Ruesch R. Frazier C. Jochheim K. Natarajan K. Jessop M. Saeed F. Moffatt S. Madren S. Thiam K. Altria |
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| 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 & Development Incorporation, 145 King of Prussia Road, Radnor, PA 19087, USA;(4) Analytical Development, Chiron Corporation, 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, Ottawa, ON, K1A 0L2, 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 |
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| Abstract: | An international project team (including members from US, Canada and UK) has been formed from a number of interested biopharmaceutical companies and regulatory authorities to conduct a cross-organisation collaboration exercise. The results from this exercise demonstrate the robustness of CE-SDS across eight different organisations that used instruments of the same equipment model, the same reagents, and the same methodology. Data generated from the analysis of a series of molecular weight markers showed very good precision with regards to relative migration time (RMT) both within and between organisations. The apparent molecular weight of bovine serum albumin (BSA) was measured with good precision to within approximately 2% RSD across the participants. A representative IgG sample showed similar results with regards to relative migration time of its 3 main components, IgG Light Chain, IgG Non-glycosylated Heavy Chain, and IgG Heavy Chain. Fractional peak area for each peak also showed good agreement, with less than 9% RSD for all peaks. This exercise will facilitate both increased regulatory and industrial opinion of CE for biopharmaceutical analysis.CE in the Biotechnology & Pharmaceutical Industries: 7th Symposium on the Practical Applications for the Analysis of Proteins, Nucleotides and Small Molecules, Montreal, Canada, August 12–16, 2005 |
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| Keywords: | Capillary electrophoresis Collaboration exercise Biopharmaceutical analysis CE-SDS |
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