RPLC of intact proteins using sub-0.5 μm particles and commercial instrumentation

Analytical Chemistry

Volumn 85, Issue 14, 2013, Pages 6820-6825

  Rogers, Benjamin J ^a   Birdsall, Robert E ^a   Wu, Zhen ^a   Wirth, Mary J ^a  

^a PURDUE UNIVERSITY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BASELINE RESOLUTION; COLLOIDAL CRYSTALS; COMMERCIAL INSTRUMENTS; FLUORESCENCE DETECTION; HIGHER RESOLUTION; PARTICLE DIAMETERS; PROTEIN SEPARATIONS; SMALL PARTICLES;

DIMERS; MONOCLONAL ANTIBODIES;

INSTRUMENTS;

BOVINE SERUM ALBUMIN; PROTEIN; SILICON DIOXIDE;

ANIMAL; ARTICLE; CATTLE; CHEMISTRY; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HUMAN; METHODOLOGY; PARTICLE SIZE; TANDEM MASS SPECTROMETRY;

ANIMALS; CATTLE; CHROMATOGRAPHY, HIGH PRESSURE LIQUID; HUMANS; PARTICLE SIZE; PROTEINS; SERUM ALBUMIN, BOVINE; SILICON DIOXIDE; TANDEM MASS SPECTROMETRY;

EID: 84880526157     PISSN: 00032700     EISSN: 15206882     Source Type: Journal    
DOI: 10.1021/ac400982w     Document Type: Article

References (26)

1. Hu, G. Understanding the basics of peptide and protein production BioProcess Int. 2010, 8 (4) 22-25
2. Liu, H.; Gaza-Bulseco, G.; Faldu, D.; Chumsae, C.; Sun, J. Heterogeneity of monoclonal antibodies J. Pharm. Sci. 2008, 97, 2426-2447
3. Wang, X.; Das, T. K.; Singh, S. K.; Kumar, S. Potential aggregation prone regions in biotherapeutics: A survey of commercial monoclonal antibodies mAbs 2009, 1, 254-267
4. Kayser, V.; Chennamsetty, N.; Voynov, V.; Helk, B.; Forrer, K.; Trout, B. L. Evaluation of a non-arrhenius model for therapeutic monoclonal antibody aggregation J. Pharm. Sci. 2011, 100, 2526-2542
5. Fesinmeyer, R.; Hogan, S.; Saluja, A.; Brych, S.; Kras, E.; Narhi, L.; Brems, D.; Gokarn, Y. Effect of ions on agitation- and temperature-induced aggregation reactions of antibodies Pharm. Res. 2009, 26, 903-913
6. Kayser, V.; Chennamsetty, N.; Voynov, V.; Forrer, K.; Helk, B.; Trout, B. L. Glycosylation influences on the aggregation propensity of therapeutic monoclonal antibodies Biotechnol. J. 2011, 6, 38-44
7. Hari, S. B.; Lau, H.; Razinkov, V. I.; Chen, S.; Latypov, R. F. Acid-induced aggregation of human monoclonal IgG1 and IgG2: Molecular mechanism and the effect of solution composition Biochemistry 2010, 49, 9328-9338
8. Bee, J. S.; Davis, M.; Freund, E.; Carpenter, J. F.; Randolph, T. W. Aggregation of a monoclonal antibody induced by adsorption to stainless steel Biotechnol. Bioeng. 2010, 105, 121-129
9. Braun, A.; Kwee, L.; Labow, M. A.; Alsenz, J. Protein aggregates seem to play a key role among the parameters influencing the antigenicity of interferon alpha (IFN-α) in normal and transgenic mice Pharm. Res. 1997, 14, 1472-1478
10. Gabrielson, J. P.; Brader, M. L.; Pekar, A. H.; Mathis, K. B.; Winter, G.; Carpenter, J. F.; Randolph, T. W. Quantitation of aggregate levels in a recombinant humanized monoclonal antibody formulation by size-exclusion chromatography, asymmetrical flow field flow fractionation, and sedimentation velocity J. Pharm. Sci. 2007, 96, 268-279
11. Santora, L. C.; Kaymakcalan, Z.; Sakorafas, P.; Krull, I. S.; Grant, K. Characterization of noncovalent complexes of recombinant human monoclonal antibody and antigen using cation exchange, size exclusion chromatography, and BIAcore Anal. Biochem. 2001, 299, 119-129
12. Patience, R. L.; Rees, L. H. Comparison of reversed-phase and anion-exchange high-performance liquid chromatography for the analysis of human growth hormones J. Chromatogr., A 1986, 352, 241-253
13. Yan, B.; Valliere-Douglass, J.; Brady, L.; Steen, S.; Han, M.; Pace, D.; Elliott, S.; Yates, Z.; Han, Y.; Balland, A.; Wang, W.; Pettit, D. Analysis of post-translational modifications in recombinant monoclonal antibody IgG1 by reversed-phase liquid chromatography/mass spectrometry J. Chromatogr., A 2007, 1164, 153-161
14. Fekete, S.; Rudaz, S.; Fekete, J.; Guillarme, D. Analysis of recombinant monoclonal antibodies by RPLC: Toward a generic method development approach J. Pharm. Biomed. Anal. 2012, 70, 158-168
15. Zhiqiang, A. Therapeutic Monoclonal Antibodies: From Bench to Clinic; J. Wiley & Sons: Hoboken, NJ, 2009.
16. MacNair, J. E.; Patel, K. D.; Jorgenson, J. W. Ultrahigh pressure reversed-phase capillary liquid chromatography: Isocratic and gradient elution using columns packed with 1.0-mu m particles Anal. Chem. 1999, 71, 700-708
17. Wu, N. J.; Liu, Y. S.; Lee, M. L. Sub-2 mu m porous and nonporous particles for fast separation in reversed-phase high performance liquid chromatography J. Chromatogr., A 2006, 1131, 142-150
18. Eschelbach, J. W.; Jorgenson, J. W. Improved protein recovery in reversed-phase liquid chromatography by the use of ultrahigh pressures Anal. Chem. 2006, 78, 1697-1706
19. Wei, B.; Malkin, D. S.; Wirth, M. J. Plate heights below 50 nm for protein electrochromatography using silica colloidal crystals Anal. Chem. 2010, 82, 10216-10221
20. Wei, B.; Rogers, B. J.; Wirth, M. J. Slip flow in colloidal crystals for ultraefficient chromatography J. Am. Chem. Soc. 2012, 134, 10780-10782
21. Rogers, B. J.; Wirth, M. J. Slip flow through colloidal crystals of varying particle diameter ACS Nano 2013, 10.1021/nn305028f
22. Jiang, P.; Bertone, J. F.; Hwang, K. S.; Colvin, V. L. Single-crystal colloidal multilayers of controlled thickness Chem. Mater. 1999, 11, 2132-2140
23. Malkin, D. S.; Wei, B.; Fogiel, A. J.; Staats, S. L.; Wirth, M. J. Submicrometer plate heights for capillaries packed with silica colloidal crystals Anal. Chem. 2010, 82, 2175-2177
24. de Frutos, M.; Cifuentes, A.; Diez-Masa, J. C.; Camafeita, E.; Mendez, E. Multiple peaks in HPLC of proteins: Bovine serum albumin eluted in a reversed-phase system J. High Resolut. Chromatogr. 1998, 21, 18-24
25. Diederich, P.; Hansen, S. K.; Oelmeier, S. A.; Stolzenberger, B.; Hubbuch, J. A sub-two minutes method for monoclonal antibody-aggregate quantification using parallel interlaced size exclusion high performance liquid chromatography J. Chromatogr., A 2011, 1218, 9010-9018
26. Mahler, H. C.; Friess, W.; Grauschopf, U.; Kiese, S. Protein aggregation: Pathways, induction factors and analysis J. Pharm. Sci. 2009, 98, 2909-2934