High resolution reversed phase analysis of recombinant monoclonal antibodies by ultra-high pressure liquid chromatography column coupling

Journal of Pharmaceutical and Biomedical Analysis

Volumn 83, Issue , 2013, Pages 273-278

  Fekete, Szabolcs ^a   Dong, Michael W ^b   Zhang, Taylor ^b   Guillarme, Davy ^a  

^a UNIVERSITY OF GENEVA   (Switzerland)

^b GENENTECH INC   (United States)

Author keywords

High resolution separations; High temperature; MAbs; Monoclonal antibodies; Peak capacity; UHPLC

Indexed keywords

MONOCLONAL ANTIBODY; RECOMBINANT MONOCLONAL ANTIBODY; UNCLASSIFIED DRUG;

ARTICLE; HYDRODYNAMICS; MASS SPECTROMETRY; PARTICLE SIZE; PEPTIDE MAPPING; PRIORITY JOURNAL; PROTEIN ANALYSIS; REVERSED PHASE LIQUID CHROMATOGRAPHY; TEMPERATURE; ULTRA PERFORMANCE LIQUID CHROMATOGRAPHY;

ANTIBODIES, MONOCLONAL; CHROMATOGRAPHY, HIGH PRESSURE LIQUID; CHROMATOGRAPHY, REVERSE-PHASE; POROSITY; RECOMBINANT PROTEINS;

EID: 84879252872     PISSN: 07317085     EISSN: 1873264X     Source Type: Journal    
DOI: 10.1016/j.jpba.2013.05.022     Document Type: Article

References (22)

1. Fekete S., Gassner A.L., Rudaz S., Schappler J., Guillarme D. Analytical strategies for the characterization of therapeutic monoclonal antibodies. Trends in Anal. Chem. 2013, 42:74-83.
2. Reichert J.M. Antibody-based therapeutics to watch in 2011. mAbs 2011, 3:76-99.
3. http://www.fiercepharma.com/special-reports/rituxan.
4. Hansel T.T., Kropshofer H., Singer T., Mitchell J.A., George A.J.T. The safety and side effects of monoclonal antibodies. Nat. Rev. Drug Discov. 2010, 9:325-338.
5. Scolnik P.A. MAbs: a business perspective. mAbs 2009, 1:179-184.
6. Mould D.R., Sweeney K.R.D. The pharmacokinetics and pharmacodynamics of monoclonal antibodies. Curr. Opin. Drug Discov. Devel. 2007, 10:84-96.
7. Edelman G.M., Cunningham B.A., Gall W.E., Gottlieb P.D., Rutishauser U., Waxdal M.J. The covalent structure of an entire gamma G immunoglobulin molecule. J. Immunol. 2004, 173:5335-5342.
8. Grotefend S., Kaminski L., Wroblewitz S., Deeb S.E., Kühn N., Reichl S., Limberger M., Watt S., Wätzig H. Protein quantitation using various modes of high performance liquid chromatography. J. Pharm. Biomed. Anal. 2012, 74:127-138.
9. Fekete S., Berky R., Fekete J., Veuthey J.L., Guillarme D. Evaluation of recent very efficient wide-pore stationary phases for the reversed-phase separation of proteins. J. Chromatogr. A 2012, 1252:90-103.
10. Fekete S., Berky R., Fekete J., Veuthey J.L., Guillarme D. Evaluation of a new wide pore core-shell material (AerisTM WIDEPORE) and comparison with other existing stationary phases for the analysis of intact proteins. J. Chromatogr. A 2012, 1236:177-188.
11. Fekete S., Guillarme D. Reversed-phase liquid chromatography for the analysis of therapeutic proteins and recombinant monoclonal antibodies. LCGC Europe 2012, 25:540-550.
12. Fekete S., Veuthey J.L., Eeltink S., Guillarme D. Comparative study of recent wide-pore materials of different stationary phase morphology, applied for the reversed-phase analysis of recombinant monoclonal antibodies. Anal. Bioanal. Chem. 2013, 405:3137-3151.
13. Krull I.S., Rathore A. Current application of UHPLC in biotechnology. Part: 1. LCGC North Am. 2011, 29:838-852.
14. Lundell N., Schreitmuller T. Sample preparation for peptide mapping - a pharmaceutical quality-control perspective. Anal. Biochem. 1999, 266:31-47.
15. Neue U.D. J. Chromatogr. A 2005, 1079:153.
16. Snyder L.R. Gradient elution. In HPLC: Advances and Perspectives 1980, vol. 1:208-316. Academic Press, New York.
17. Snyder L.R., Kirkland J.J., Glajch J.L. Practical HPLC Method Development 1997, John Wiley & Sons Inc., New York. 2nd ed.
18. Nyiredy S., Szücs Z., Szepesy L. Stationary phase optimized selectivity liquid chromatography: basic possibilities of serially connected columns using the "PRISMA" principle. J. Chromatogr. A 2007, 1157:122-130.
19. Fekete S.S., Rudaz S., Veuthey J.L., Guillarme D. Impact of mobile phase temperature on recovery and stability of monoclonal antibodies using recent reversed-phase stationary phases. J. Sep. Sci. 2012, 35:3113-3123.
20. Fekete S.S., Veuthey J.L., McCalley D.M., Guillarme D. The effect of pressure and mobile phase velocity on the retention properties of small analytes and large biomolecules in ultra-high pressure liquid chromatography. J. Chromatogr. A 2012, 1270:127-138.
21. Ruta J., Guillarme D., Rudaz S., Veuthey J.L. Comparison of columns packed with porous sub-2μm particles and superficially porous sub-3μm particles for peptide analysis at ambient and high temperature. J. Sep. Sci. 2010, 33:2465-2477.
22. Wagner B.M., Schuster S.A., Boyes B.E., Kirkland J.J. Superficially porous silica particles with wide pores for biomacromolecular separations. J. Chromatogr. A 2012, 1264:22-30.