Micelle-Associated Protein in Epoetin Formulations: A Risk Factor for Immunogenicity?

Pharmaceutical Research

Volumn 20, Issue 12, 2003, Pages 1903-1907

  Hermeling, Suzanne ^a,b   Schellekens, Huub ^b   Crommelin, Daan J A ^a   Jiskoot, Wim ^a  

^a UTRECHT UNIVERSITY   (Netherlands)

^b UTRECHT UNIVERSITY   (Netherlands)

Author keywords

Epoetin; Erythropoietin; Immunogenicity; Micelles; Protein formulation; Tween

Indexed keywords

MICELLE ASSOCIATED PROTEIN; NEUTRALIZING ANTIBODY; POLYSORBATE 80; PROTEIN; RECOMBINANT ERYTHROPOIETIN; UNCLASSIFIED DRUG;

ANTIBODY PRODUCTION; ARTICLE; DRUG FORMULATION; DRUG MECHANISM; ELUTION; ENZYME LINKED IMMUNOSORBENT ASSAY; GEL PERMEATION CHROMATOGRAPHY; HUMAN; IMMUNOASSAY; IMMUNOGENICITY; MICELLE; PRIORITY JOURNAL; PURE RED CELL ANEMIA; RISK FACTOR; ULTRAVIOLET RADIATION;

CHEMISTRY, PHARMACEUTICAL; CHROMATOGRAPHY, GEL; EPOETIN ALFA; EXCIPIENTS; HEMATINICS; HUMANS; IMMUNOASSAY; MOLECULAR WEIGHT; POLYSORBATES; SPECTROPHOTOMETRY, ULTRAVIOLET;

EID: 0347477301     PISSN: 07248741     EISSN: None     Source Type: Journal    
DOI: 10.1023/B:PHAM.0000008034.61317.02     Document Type: Article

References (14)

1. G. Walsh. Pharmaceutical biotechnology products approved within the European Union. Eur. J. Pharm. Biopharm. 55:3-10 (2003).
2. E. Koren, L. A. Zuckerman, and A. R. Mire-Sluis. Immune responses to therapeutic proteins in humans-clinical significance, assessment and prediction. Curr. Pharm. Biotechnol. 3:349-360 (2002).
3. F. Adair and D. Ozanne. The immunogenicity of therapeutic proteins. BioPharm February:30-36 (2002).
4. H. Schellekens. Bioequivalence and the immunogenicity of biopharmaceuticals. Nat. Rev. Drug Discov. 1:457-462 (2002).
5. A. Braun, L. Kwee, M. A. Labow, and J. Alsenz. Protein aggregates seem to play a key role among the parameters influencing the antigenicity of interferon alpha (IFN-alpha) in normal and transgenic mice. Pharm. Res. 14:1472-1478 (1997).
6. G. Schernthaner. Immunogenicity and allergenic potential of animal and human insulins. Diabetes Care 16(Suppl 3):155-165 (1993).
7. W. V. Moore and P. Leppert. Role of aggregated human growth hormone (hGH) in development of antibodies to hGH. J. Clin. Endocrinol. Metab. 51:691-697 (1980).
8. E. Hochuli. Interferon immunogenicity: technical evaluation of interferon-alpha 2a. J. Interferon Cytokine Res. 17(Suppl 1):S15-S21 (1997).
9. H. F. Bunn. Drug-induced autoimmune red-cell aplasia. N. Engl. J. Med. 346:522-523 (2002).
10. N. Casadevall, J. Nataf, B. Viron, A. Kolta, J. J. Kiladjian, P. Martin-Dupont, P. Michaud, T. Papo, V. Ugo, I. Teyssandier, B. Varet, and P. Mayeux. Pure red-cell aplasia and antierythropoietin antibodies in patients treated with recombinant erythropoietin. N. Engl. J. Med. 346:469-475 (2002).
11. S. K. Gershon, H. Luksenburg, T. R. Cote, and M. M. Braun. Pure red-cell aplasia and recombinant erythropoietin. N. Engl. J. Med. 346:1584-1586 (2002).
12. N. Casadevall. Antibodies against rHuEPO: native and recombinant. Nephrol. Dial. Transplant. 17(Suppl 5):42-47 (2002).
13. L. S. Wan and P. F. Lee. CMC of polysor bates. J. Pharm. Sci. 63:136-137 (1974).
14. R. M. Zinkernagel. Uncertainties - discrepancies in immunology. Immunol. Rev. 185:103-125 (2002).