Improved detection of variants in recombinant human interferon alpha-2a products by reverse-phase high-performance liquid chromatography on a core-shell stationary phase

Journal of Pharmaceutical and Biomedical Analysis

Volumn 88, Issue , 2014, Pages 123-129

  Li, Yonghong ^a   Rao, Chunming ^a   Tao, Lei ^a   Wang, Junzhi ^a   Lorbetskie, Barry ^b   Girard, Michel ^b  

^a NATIONAL INSTITUTES FOR FOOD AND DRUG CONTROL   (China)

^b HEALTH CANADA   (Canada)

Author keywords

Core shell; HPLC; Interferon alpha 2a; Quality control; Variants

Indexed keywords

ACETONITRILE; RECOMBINANT ALPHA2A INTERFERON; TRIFLUOROACETIC ACID;

ARTICLE; CONTROLLED STUDY; DRUG DETERMINATION; ELUTION; FLUORESCENCE; INTERMETHOD COMPARISON; PRIORITY JOURNAL; PROTEIN ANALYSIS; REVERSED PHASE HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; SEPARATION TECHNIQUE; TEMPERATURE; VALIDITY;

CORE-SHELL; HPLC; INTERFERON ALPHA-2A; QUALITY CONTROL; VARIANTS;

CHEMISTRY TECHNIQUES, ANALYTICAL; CHEMISTRY, PHARMACEUTICAL; CHROMATOGRAPHY, HIGH PRESSURE LIQUID; DNA, RECOMBINANT; HUMANS; INTERFERON-ALPHA; INTERFERONS; METHIONINE; OXYGEN; PEPTIDES; PROTEIN STRUCTURE, TERTIARY; QUALITY CONTROL; RECOMBINANT PROTEINS; REPRODUCIBILITY OF RESULTS; TANDEM MASS SPECTROMETRY; TEMPERATURE;

EID: 84884272299     PISSN: 07317085     EISSN: 1873264X     Source Type: Journal    
DOI: 10.1016/j.jpba.2013.08.011     Document Type: Article

References (29)

1. George P.M., Badiger R., Alazawi W., Foster G.R., Mitchell J.A. Pharmacology and therapeutic potential of interferons. Pharmacol. Ther. 2012, 135:44-53.
2. Quesada J.R., Gutterman J.U., Hersh E.M. Treatment of hairy cell leukemia with alpha interferons. Cancer 1986, 57:1678-1680.
3. Muss H.B. Interferon therapy for renal cell carcinoma. Semin. Oncol. 1987, 14:36-42.
4. Rusciani L., Petraglia S., Alotto M., Calvieri S., Vezzoni G. Postsurgical adjuvant therapy for melanoma. Evaluation of a 3-year randomized trial with recombinant interferon-alpha after 3 and 5 years of follow-up. Cancer 1997, 79:2354-2360.
5. Kirkwood J. Cancer immunotherapy: the interferon-alpha experience. Semin. Oncol. 2002, 29:18-26.
6. Feld J.J., Hoofnagle J.H. Mechanism of action of interferon and ribavirin in treatment of hepatitis C. Nature 2005, 436:967-972.
7. Ahrer K., Jungbauer A. Chromatographic and electrophoretic characterization of protein variants. J. Chromatogr. B Analyt. Technol. Biomed. Life Sci. 2006, 841:110-122.
8. Jenkins N., Murphy L., Tyther R. Post-translational modifications of recombinant proteins: significance for biopharmaceuticals. Mol. Biotechnol. 2008, 39:113-118.
9. Karlsson G., Gellerfors P., Persson A., Noren B., Edlund P.O., Sandberg C., Birnbaum S. Separation of oxidized and deamidated human growth hormone variants by isocratic reversed-phase high-performance liquid chromatography. J. Chromatogr. A 1999, 855:147-155.
10. Manning M.C., Chou D.K., Murphy B.M., Payne R.W., Katayama D.S. Stability of protein pharmaceuticals: an update. Pharm. Res. 2010, 27:544-575.
11. Moorhouse K.G., Nashabeh W., Deveney J., Bjork N.S., Mulkerrin M.G., Ryskamp T. Validation of an HPLC method for the analysis of the charge heterogeneity of the recombinant monoclonal antibody IDEC-C2B8 after papain digestion. J. Pharm. Biomed. Anal. 1997, 16:593-603.
12. European Directorate for the Quality of Medicines and HealthCare, Interferon alpha-2 concentrated solution, in: European Pharmacopoeia, seventh ed., Council of Europe, Strasbourg (France), 2011, pp. 2252-2255.
13. Edman P. A method for the determination of amino acid sequence in peptides. Arch. Biochem. 1949, 22:475.
14. Fekete S., Veuthey J.L., Guillarme D. New trends in reversed-phase liquid chromatographic separations of therapeutic peptides and proteins: theory and applications. J. Pharm. Biomed. Anal. 2012, 69:9-27.
15. Fekete S., Berky R., Fekete J., Veuthey J.L., Guillarme D. Evaluation of a new wide pore core-shell material (Aeris WIDEPORE) and comparison with other existing stationary phases for the analysis of intact proteins. J. Chromatogr. A 2012, 1236:177-188.
16. Diress A., Lorbetskie B., Larocque L., Li X., Alteen M., Isbrucker R., Girard M. Study of aggregation, denaturation and reduction of interferon alpha-2 products by size-exclusion high-performance liquid chromatography with fluorescence detection and biological assays. J. Chromatogr. A 2010, 1217:3297-3306.
17. Marcker K., Sanger F. N-Formyl-Methionyl-S-Rna. J. Mol. Biol. 1964, 8:835-840.
18. Adams J.M. On the release of the formyl group from nascent protein. J. Mol. Biol. 1968, 33:571-589.
19. Takeda M., Webster R.E. Protein chain initiation and deformylation in B. subtilis homogenates. Proc. Natl. Acad. Sci. USA 1968, 60:1487-1494.
20. Moerschell R.P., Hosokawa Y., Tsunasawa S., Sherman F. The specificities of yeast methionine aminopeptidase and acetylation of amino-terminal methionine in vivo. Processing of altered iso-1-cytochromes c created by oligonucleotide transformation. J. Biol. Chem. 1990, 265:19638-19643.
21. Chaudhuri T.K., Horii K., Yoda T., Arai M., Nagata S., Terada T.P., Uchiyama H., Ikura T., Tsumoto K., Kataoka H., Matsushima M., Kuwajima K., Kumagai I. Effect of the extra n-terminal methionine residue on the stability and folding of recombinant alpha-lactalbumin expressed in Escherichia coli. J. Mol. Biol. 1999, 285:1179-1194.
22. Mine S., Ueda T., Hashimoto Y., Imoto T. Improvement of the refolding yield and solubility of hen egg-white lysozyme by altering the Met residue attached to its N-terminus to Ser. Protein Eng. 1997, 10:1333-1338.
23. Hargrove M.S., Krzywda S., Wilkinson A.J., Dou Y., Ikeda-Saito M., Olson J.S. Stability of myoglobin: a model for the folding of heme proteins. Biochemistry 1994, 33:11767-11775.
24. Newton D.L., Boque L., Wlodawer A., Huang C.Y., Rybak S.M. Single amino acid substitutions at the N-terminus of a recombinant cytotoxic ribonuclease markedly influence biochemical and biological properties. Biochemistry 1998, 37:5173-5183.
25. Adinolfi B.S., Cafaro V., D'Alessio G., Di Donato A. Full antitumor action of recombinant seminal ribonuclease depends on the removal of its N-terminal methionine. Biochem. Biophys. Res. Commun. 1995, 213:525-532.
26. Proudfoot A.E., Power C.A., Hoogewerf A.J., Montjovent M.O., Borlat F., Offord R.E., Wells T.N. Extension of recombinant human RANTES by the retention of the initiating methionine produces a potent antagonist. J. Biol. Chem. 1996, 271:2599-2603.
27. Schlott B., Hartmann M., Guhrs K.H., Birch-Hirschfeid E., Pohl H.D., Vanderschueren S., Van de Werf F., Michoel A., Collen D., Behnke D. High yield production and purification of recombinant staphylokinase for thrombolytic therapy. Biotechnology (NY) 1994, 12:185-189.
28. Shirokov V.V.R.D.A., Akishina R.I., Ospelnikova T.P., Glazunov A.V., Chestukhina G.G., Veiko V.P. Development of hybrid human interferon alfa-2 strain-producers and the use of enteropeptidase for production of N-terminal methionine-free interferons. Mol. Biol. 2011, 45:466-471.
29. Cindric M., Galic N., Vuletic M., Klaric M., Drevenkar V. Evaluation of recombinant human interferon alpha-2b structure and stability by in-gel tryptic digestion, H/D exchange and mass spectrometry. J. Pharm. Biomed. Anal. 2006, 40:781-787.