Analysis of charge heterogeneities in mAbs using imaged CE

Electrophoresis

Volumn 30, Issue 5, 2009, Pages 714-722

  He, Xiaoping Z ^a   Que, Amy H ^b   Mo, Jim J ^a  

^a PFIZER GLOBAL RESEARCH AND DEVELOPMENT   (United States)

^b GENENTECH INC   (United States)

Author keywords

Charge heterogeneity; Generic method; Imaged CE; Therapeutic mAb

Indexed keywords

CLINICAL RESEARCH; ELECTROPHORESIS; ICE; IMAGE ANALYSIS; ION EXCHANGE; LIQUID CHROMATOGRAPHY; QUALITY CONTROL;

ANALYTICAL METHOD; CHARGE HETEROGENEITY; CHARGE VARIANTS; CONTROL PURPOSE; GENERIC METHOD; IMAGED CE; ION EXCHANGE LIQUID CHROMATOGRAPHY; ION-EXCHANGE METHODS; RESEARCH PURPOSE; THERAPEUTIC MAB;

MOLECULES;

ACETIC ACID; MONOCLONAL ANTIBODY; SODIUM CHLORIDE;

ANTIBODY PRODUCTION; ARTICLE; BIOINFORMATICS; CAPILLARY ELECTROPHORESIS; CONTROLLED STUDY; DRUG MANUFACTURE; DRUG RELEASE; DRUG STABILITY; ELECTROPHORESIS; HIGH THROUGHPUT SCREENING; IMAGED CAPILLARY ELECTROPHORESIS; ION EXCHANGE CHROMATOGRAPHY; LIQUID CHROMATOGRAPHY; MEDICAL RESEARCH; PH; PROCESS DEVELOPMENT; QUALITY CONTROL; QUANTITATIVE ANALYSIS;

EID: 65949125092     PISSN: 01730835     EISSN: 15222683     Source Type: Journal    
DOI: 10.1002/elps.200800636     Document Type: Article

References (18)

1. Righetti, P. G., Isoelectric Focusing: Theory, Methodology and Applications, Elsevier Scientific, Amsterdam 1983.
2. Tang, S., Nesta, D. P., Maneri, L. R., Anumula, K. R., J. Pharm. Biomed. Anal. 1999, 19, 569-583.
3. Monitoring Stability of Monoclonal Antibodies by Cation-Exchange Chromatography, Dionex Application Note 128.
4. Analysis of Monoclonal Antibody Heterogeneity by Cation-Exchange Chromatography: Separation of C-Terminal Lysine Variants, Dionex Application Note 127.
5. Hjerten S, Zhu M., J. Chromatogr. 1985, 346, 265-270.
6. Pritchet, T. J., Electrophoresis 1996, 17, 1195-1201.
7. Wu J., Li, S., Pawliszyn, J., J. Chromatogr. B 1998, 817, 163-171.
8. Wu, J., Watson, A. H., Torres, A. R., Am. Biotechnol. Lab. 1999, 17, 24-26.
9. Goodridge, L., Goodridge, C., Wu, J., Griffiths, M. et al., Anal. Chem. 2004, 76, 48-52.
10. Wu, J., Pawliszyn, J., J. Chromatogr. B 1994, 657, 327-334.
11. Mao, Q., Pawliszyn, J., J. Biochem. Biophy. Methods 1999, 39, 93-110.
12. Wu, J., Wu, X. Z., Huang, T., Pawliszyn, J., Methods Mol. Biol. 2004, 276, 229-252.
13. Janini, G., Saptharishi, N., Waselus, M., Soman, G., Electrophoresis, 2002, 23, 1605-1611.
14. Li, N., Kessler, K., Bass, L., Zheng, D., J. Pharm. Biomed. Anal., 2007, 43, 963-972.
15. Quan, C., Alcala, E., Petkovska, I., Matthews, D. et al., Anal. Biochem., 2008, 373, 179-191.
16. He, X. Z., Mo, J., Application and Validation of Generic iCE Method for the Determination of Charge Variants in Therapeutic mAbs, manuscript in preparation.
17. Bhuyan, A. K., Biochemistry. 2002, 41, 13386-13394.
18. Ueda2, T., Nagata, M., Imoto, T., J. Biochem., 2001, 130, 491-496.