Rapid analysis of charge variants of monoclonal antibodies using non-linear salt gradient in cation-exchange high performance liquid chromatography

Journal of Chromatography A

Volumn 1406, Issue , 2015, Pages 175-185

  Joshi, Varsha ^a   Kumar, Vijesh ^a   Rathore, Anurag S ^a  

^a INDIAN INSTITUTE OF TECHNOLOGY DELHI   (India)

Author keywords

CE HPLC; Concave gradient; Convex gradient; MAb; PAT; Sigmoidal gradient

Indexed keywords

MONOCLONAL ANTIBODIES; POSITIVE IONS; SODIUM CHLORIDE;

CATION EXCHANGES; CHARGE HETEROGENEITY; CONVENTIONAL METHODS; ELUTION GRADIENT; LIMIT OF DETECTION; LIMIT OF QUANTIFICATIONS; SIGMOIDAL SHAPE; STEP-BY-STEP APPROACH;

HIGH PERFORMANCE LIQUID CHROMATOGRAPHY;

IMMUNOGLOBULIN G1 ANTIBODY; MONOCLONAL ANTIBODY; SODIUM CHLORIDE; SODIUM DIHYDROGEN PHOSPHATE; CATION; PHOSPHATE;

ANALYSIS; ANALYSIS TIME; ARTICLE; CATION EXCHANGE HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; COLUMN LENGTH; CONCENTRATION (PARAMETERS); CONTROLLED STUDY; ELUTION; ELUTION GRADIENT SHAPE; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; LIMIT OF DETECTION; LIMIT OF QUANTITATION; LINEARITY; MEASUREMENT REPEATABILITY; PARAMETERS; PH; PRIORITY JOURNAL; SENSITIVITY AND SPECIFICITY; TEMPERATURE; CHEMICAL ANALYSIS; CHEMISTRY; ION EXCHANGE CHROMATOGRAPHY; PROCEDURES;

ANTIBODIES, MONOCLONAL; CATIONS; CHEMISTRY TECHNIQUES, ANALYTICAL; CHROMATOGRAPHY, HIGH PRESSURE LIQUID; CHROMATOGRAPHY, ION EXCHANGE; LIMIT OF DETECTION; PHOSPHATES; SODIUM CHLORIDE;

EID: 84937634304     PISSN: 00219673     EISSN: 18733778     Source Type: Journal    
DOI: 10.1016/j.chroma.2015.06.015     Document Type: Article

References (45)

1. Reichert J.M. Monoclonal antibodies as innovative therapeutics. Curr. Pharm. Biotechnol. 2008, 9:423-430.
2. He Y., Isele C., Hou W., Ruesch M. Rapid analysis of charge variants of monoclonal antibodies with capillary zone electrophoresis in dynamically coated fused-silica capillary. J. Sep. Sci. 2011, 34:548-555.
3. Weinberg W.C., Frazier-Jessen M.R., Wu W.J., Weir A., Hartsough M., Keegan P., Fuchs C. Development and regulation of monoclonal antibody products: challenges and opportunities. Cancer Metastasis Rev. 2005, 24:569-584.
4. Talebi M., Nordborg A., Gaspar A., Lacher N.A., Wang Q., He X.Z., Haddad P.R., Hilder E.F. Charge heterogeneity profiling of monoclonal antibodies using low ionic strength ion-exchange chromatography and well-controlled pH gradients on monolithic columns. J. Chromatogr. A 2013, 1317:148-154S.
5. Fekete A.-L., Gassner S., Rudaz J., Schappler D., Guillarme Analytical strategies for the characterization of therapeutic monoclonal antibodies. TrAC-Trend Anal. Chem. 2013, 42:74-83.
6. Kálmán-Szekeres Z., Olajos M., Ganzler K. Analytical aspects of biosimilarity issues of protein drugs. J. Pharm. Biomed. Anal. 2012, 69:185-195.
7. Filipe V., Hawe A., Carpenter J.F., Jiskoot W. Analytical approaches to assess the degradation of therapeutic proteins. TrAC-Trend Anal. Chem. 2013, 49:118-125.
8. Beck A., Diemer H., Ayoub D., Debaene F., Wagner-Rousset E., Carapito C., Van Dorsselaer A., Sanglier-Cianférani S. Analytical characterization of biosimilar antibodies and Fc-fusion proteins. TrAC-Trend Anal. Chem. 2013, 48:81-95.
9. Ahrer K., Jungbauer A. Chromatographic and electrophoretic characterization of protein variants. J. Chromatogr. B 2006, 841:110-122.
10. Fekete S., Beck A., Fekete J., Guillarme D. Method development for the separation of monoclonal antibody charge variants in cation exchange chromatography, Part I: Salt gradient approach. J. Pharm. Biomed. Anal. 2015, 102:33-44.
11. Fekete S., Beck A., Fekete J., Guillarme D. Method development for the separation of monoclonal antibody charge variants in cation exchange chromatography, Part II: pH gradient approach. J. Pharm. Biomed. Anal. 2015, 102:282-289.
12. Link A.J. Multidimensional peptide separations in proteomics. Trends Biotechnol. 2002, 20:s8-s13.
13. Ahamed T., Chilamkurthi S., Nfor B.K., Verhaert P.D., van Dedem G.W., van der Wielen L.A., Eppink M.H., van de Sandt E.J., Ottens M. Selection of pH-related parameters in ion-exchange chromatography using pH-gradient operations. J. Chromatogr. A 2008, 1194:22-29.
14. Tsonev L.I., Hirsh A.G. Theory and applications of a novel ion exchange chromatographic technology using controlled pH gradients for separating proteins on anionic and cationic stationary phases. J. Chromatogr. A 2008, 1200:166-182.
15. Lingg N., Tan E., Hintersteiner B., Bardor M., Jungbauer A. Highly linear pH gradients for analyzing monoclonal antibody charge heterogeneity in the alkaline range. J. Chromatogr. A 2013, 1319:65-71.
16. Talebi M., Shellie R.A., Hilder E.F., Lacher N.A., Haddad P.R. Semiautomated pH gradient ion-exchange chromatography of monoclonal antibody charge variants. Anal. Chem. 2014, 86:9794-9799.
17. Vlasak J., Ionescu R. Heterogeneity of monoclonal antibodies revealed by charge-sensitive methods. Curr. Pharm. Biotechnol. 2008, 9:468-481.
18. Rea J.C., Moreno G.T., Lou Y., Farnan D. Validation of a pH gradient-based ion-exchange chromatography method for high-resolution monoclonal antibody charge variant separations. J. Pharm. Biomed. Anal. 2011, 54:317-323.
19. Kaltenbrunner O., Tauer C., Brunner J., Jungbauer A. Isoprotein analysis by ion-exchange chromatography using a linear pH gradient combined with a salt gradient. J. Chromatogr 1993, 639:41-49.
20. Rozhkova A. Quantitative analysis of monoclonal antibodies by cation-exchange chromatofocusing. J. Chromatogr. A 2009, 1216:5989-5994.
21. Rathore A.S., Bhambure R., Ghare V. Process analytical technology (PAT) for biopharmaceutical products. Anal. Bioanal. Chem. 2010, 398:137-154.
22. Rathore A.S., Wood R., Sharma A., Dermawan S. Case study and application of process analytical technology (PAT) towards bioprocessing: II. Use of ultra-performance liquid chromatography (UPLC) for making real-time pooling decisions for process chromatography. Biotechnol. Bioeng. 2008, 101:1366-1374.
23. Rathore A.S., Yu M., Yeboah S., Sharma A. Case study and application of process analytical technology (PAT) towards bioprocessing: use of on-line high-performance liquid chromatography (HPLC) for making real-time pooling decisions for process chromatography. Biotechnol. Bioeng. 2008, 100:306-316.
24. Joshi V.S., Kumar V. A Rapid HPLC analysis method for enabling PAT application in processing of GCSF. LCGC North Am. 2013, 31:948-953.
25. Innovations in Biotechnology 2012, InTech, Croatia, ISBN 978-953-51-0096-6. J.C. Rea, Y.J. Wang, T.G. Moreno, R. Parikh, Y. Lou, D. Farnan, E.C. Egbo (Eds.).
26. Stadalius M., Gold H., Snyder L. Optimization model for the gradient elution separation of peptide mixtures by reversed-phase high-performance liquid chromatography: verification of retention relationships. J. Chromatogr 1985, 327:27-45.
27. Stadalius M., Gold H., Snyder L. Optimization model for the gradient elution separation of peptide mixtures by reversed-phase high-performance liquid chromatography: verification of band width relationships for acetonitrile-water mobile phases. J. Chromatogr 1984, 296:31-59.
28. Hearn M.T., Grego B. High-performance liquid chromatography of amino acids, peptides and proteins: XL. Further studies on the role of the organic modifier in the reversed-phase high-performance liquid chromatography of polypeptides. Implications for gradient optimisation. J. Chromatogr 1983, 255:125-136.
29. Zhu P., Snyder L., Dolan J., Djordjevic N., Hill D., Sander L., Waeghe T. Combined use of temperature and solvent strength in reversed-phase gradient elution I. Predicting separation as a function of temperature and gradient conditions. J. Chromatogr. A 1996, 756:21-39.
30. Shan Y., Seidel-Morgenstern A. Optimization of gradient elution conditions in multicomponent preparative liquid chromatography. J. Chromatogr. A 2005, 1093:47-58.
31. Jandera P., Kučerová Z., Urban J. Retention times and bandwidths in reversed-phase gradient liquid chromatography of peptides and proteins. J. Chromatogr. A 2011, 1218:8874-8889.
32. Tarafder A., Aumann L., Müller-Späth T., Morbidelli M. Improvement of an overloaded, multi-component, solvent gradient bioseparation through multiobjective optimization. J. Chromatogr. A 2007, 1167:42-53.
33. Joshi V.S., Kumar V., Rathore A.S. Role of organic modifier and gradient shape in RP-HPLC separation: analysis of GCSF variants. J. Chromatogr. Sci. 2015, bmu222.
34. Jandera P. Simultaneous optimisation of gradient time, gradient shape and initial composition of the mobile phase in the high-performance liquid chromatography of homologous and oligomeric series. J. Chromatogr. A 1999, 845:133-144.
35. Jandera P. Gradient elution in liquid column chromatography-prediction of retention and optimization of separation. Adv. Chromatogr. 2005, 43:I.
36. Damtew A., Sreedhar B., Seidel-Morgenstern A. Evaluation of the potential of nonlinear gradients for separating a ternary mixture. J. Chromatogr. A 2009, 1216:5355-5364.
37. Yamamoto S., Ishihara T. Ion-exchange chromatography of proteins near the isoelectric points. J. Chromatogr. A 1999, 852:31-36.
38. Fekete S., Beck A., Guillarme D. Characterization of cation exchanger stationary phases applied for the separations of therapeutic monoclonal antibodies. J. Pharm. Biomed. Anal. 2015, 111:169-176.
39. International Conference on Harmonization (ICH) Q2A: Text on Validation of Analytical Procedures. US FDA Federal Register 1995, 60:11260.
40. International Conference on Harmonization (ICH) Q2b: Validation of Analytical Procedures: Methodology. US FDA Federal Register May 1997, 62:27463.
41. ICH Secretariat International Conference on Harmonization (ICH) guideline ICH Q2(R1): Validation of Analytical Procedures: Text and Methodology 2005, ICH Secretariat, Geneva.
42. Mendhe R., Muralikrishnan T., Patil N., Rathore A.S. Comparison of PAT based approaches for making real-time pooling decisions for process chromatography-use of feed forward control. J. Chem. Technol. Biotechnol. 2015, 90:341-348.
43. Rathore A.S., Parr L., Dermawan S., Lawson K., Lu Y. Large scale demonstration of process analytical technology (PAT) in bioprocessing: use of high performance liquid chromatography (HPLC) for making real time pooling decisions for process chromatography. Biotechnol. Prog. 2010, 26:448-457.
44. Rathore A.S., Wood R., Sharma A., Dermawan S. Case study and application of process analytical technology (PAT) towards bioprocessing: II. Use of ultra performance liquid chromatography (UPLC) for making real time pooling decisions for process chromatography. Biotechnol. Bioeng. 2008, 101:1366-1374.
45. Rathore A.S., Yu M., Yeboah S., Sharma A. Case study and application of process analytical technology (PAT) towards bioprocessing: use of on-line high performance liquid chromatography (HPLC) for making real time pooling decisions for process chromatography. Biotechnol. Bioeng. 2008, 100:306-316.