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Capillary Electrophoresis of Proteins and Peptides pp 121–136Cite as

Capillary Electrophoresis of Proteins in a Quality Control Environment

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Part of the book series: Methods in Molecular Biology™ ((MIMB,volume 276))

Abstract

A method for determining the purity of recombinant carboxypeptidase B utilizing CE-SDS has been developed and validated for use in a manufacturing quality control laboratory. The method was optimized, prior to validation, to allow for the lowest limit of quantitation. The method was validated with the typical ICHQ2A parameters, including accuracy, linearity, LOQ, precision, robustness/ruggedness, and specificity. All validation parameters met the acceptance criteria defined in the validation protocol.

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References

  1. Park, S. S., Cate A., and Chang, B. S. (2001) Use of capillary electrophoresis to determine the dilute protein concentration in formulations containing interfering excipients. Chromatographia 53, S34–S38.

    Article  Google Scholar 

  2. Jochheim, C., Novick, S., Balland, A., et al. (2001) Separation of Enbrel® (rhuTNFR:Fc) isoforms by capillary isoelectric focusing. Chromatographia 53, S59–S65.

    Google Scholar 

  3. Schenerman, M. A. and Bowen, S. H. (2001) Optimization, validation, and use of capillary gel electrophoresis for quality control testing of Synagis®, a monoclonal antibody. Chromatographia 53, S66–S72.

    Google Scholar 

  4. Ma, S. and Nashabeh, W. (2001) Analysis of protein therapeutics by capillary electrophoresis. Chromatographia 53, S75–S89.

    Google Scholar 

  5. Hunt, G. and Nashabeh, W. (1999) Capillary electrophoresis sodium dodecyl sulfate nongel sieving analysis of a therapeutic recombinant monoclonal antibody: a biotechnology perspective. Anal. Chem. 71, 2390–2397.

    Article  PubMed  CAS  Google Scholar 

  6. Altria, K. D., Chen, A. B., and Clohs, L. (2001) Capillary electrophoresis as a routine analytical tool in pharmaceutical analysis. LCGC 19, 972–985.

    CAS  Google Scholar 

  7. Izco, J. M., Ordóñez, A. I., Torre, P., and Barcina, Y. (1999) Validation of capillary electrophoresis in the analysis of ewe’s milk casein. J. Chromatogr. A 832, 239–246.

    Article  PubMed  CAS  Google Scholar 

  8. Schenerman, M. A. and Bowen, S. H. (2001) Optimizing sample preparation for capillary gel electrophoresis. LCGC 19, 190–198.

    CAS  Google Scholar 

  9. Hwang, K.-H., Lee, K.-W., Kim, C.-S., Han, K., Chung, Y.-B., and Moon, D.-C. (2001) Determination of recombinant human Epidermal Growth Factor (rhEGF) in a pharmaceutical preparation by capillary electrophoresis. Arch Pharm Res 24, 601–606.

    Article  PubMed  CAS  Google Scholar 

  10. Bowen, S. H. and Schenerman, M. A. (1998) Replacing slab gel electrophoresis methods with capillary electrophoresis for quality control and stability testing. BioPharm 11, 42–50.

    CAS  Google Scholar 

  11. Wätzig, H., Degenhardt, M., and Kunkel, A. (1998) Strategies for capillary electrophoresis: method development and validation for pharmaceutical and biological applications. Electrophoresis 19, 2695–2752.

    Article  PubMed  Google Scholar 

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Author information

Authors and Affiliations

  1. Indianapolis Bulk Operations Technical Excellence Centre, Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN

    David L. Good, Stacey Cummins-Bitz & Raeann M. Fields

  2. Vaccine Analytical Development, Wyeth Research, Wyeth, Sanford, NC

    Brian K. Nunnally

Authors
  1. David L. Good
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  2. Stacey Cummins-Bitz
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  3. Raeann M. Fields
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  4. Brian K. Nunnally
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Editor information

Editors and Affiliations

  1. Eli Lilly and Company, Indianapolis, IN

    Mark A. Strege

  2. Lilly Research Laboratories, Indianapolis, IN

    Avinash L. Lagu

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© 2004 Humana Press Inc.

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Cite this protocol

Good, D.L., Cummins-Bitz, S., Fields, R.M., Nunnally, B.K. (2004). Capillary Electrophoresis of Proteins in a Quality Control Environment. In: Strege, M.A., Lagu, A.L. (eds) Capillary Electrophoresis of Proteins and Peptides. Methods in Molecular Biology™, vol 276. Humana Press. https://doi.org/10.1385/1-59259-798-X:121

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  • DOI: https://doi.org/10.1385/1-59259-798-X:121

  • Publisher Name: Humana Press

  • Print ISBN: 978-1-58829-017-5

  • Online ISBN: 978-1-59259-798-7

  • eBook Packages: Springer Protocols

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