Journal article
Optimization and qualification of capillary zone electrophoresis method for glycoprotein isoform distribution of erythropoietin for quality control laboratory
Journal of pharmaceutical and biomedical analysis, v 50(3), pp 538-543
2009
PMID: 19515523
Featured in Collection : UN Sustainable Development Goals @ Drexel
Abstract
The European Pharmacopoeia (Ph. Eur.) monograph for Erythropoietin Concentrated Solution describes a capillary zone electrophoresis method for identification of recombinant human erythropoietin. However, this method has shown poor reproducibility due to inadequate capillary conditioning. We have modified the Ph. Eur. method to make it more robust and suitable for the quality control laboratory for the analysis of epoetin alfa and epoetin alfa after formulation with polysorbate 80. This study qualified the modified method by showing improved robustness and reproducibility. The study also characterized and qualified a secondary standard of epoetin alfa as a substitute for the primary standard, Ph. Eur. erythropoietin Biological Reference Preparation, which is available in limited supply. Four sets of analyses were performed to assess repeatability, intermediate precision, and the secondary standard. The results showed that the modified method is suitable for its intended purpose to test epoetin alfa and formulated epoetin alfa samples. The epoetin alfa secondary standard is a suitable substitute for the primary standard. Further, we developed a procedure for the removal of polysorbate 80 from formulated epoetin alfa, allowing the material to be analyzed by the modified Ph. Eur. method.
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Details
- Title
- Optimization and qualification of capillary zone electrophoresis method for glycoprotein isoform distribution of erythropoietin for quality control laboratory
- Creators
- Junge Zhang - BIO Pharmaceutical Development, Centocor Research and Development, Radnor, PA, USAUtpal Chakraborty - BIO Pharmaceutical Development, Centocor Research and Development, Radnor, PA, USAAnnabelle P Villalobos - BIO Pharmaceutical Development, Centocor Research and Development, Radnor, PA, USAJohn M Brown - BIO Pharmaceutical Development, Centocor Research and Development, Radnor, PA, USAJoe P Foley - Department of Chemistry, Drexel University, 3141 Chestnut Street, Philadelphia, PA 19104, USA
- Publication Details
- Journal of pharmaceutical and biomedical analysis, v 50(3), pp 538-543
- Publisher
- Elsevier
- Resource Type
- Journal article
- Language
- English
- Academic Unit
- Chemistry
- Web of Science ID
- WOS:000268517800036
- Scopus ID
- 2-s2.0-67650215930
- Other Identifier
- 991014877830104721
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- Collaboration types
- Industry collaboration
- Domestic collaboration
- Web of Science research areas
- Chemistry, Analytical
- Pharmacology & Pharmacy