Excipient exchange in the comparison of preparations of the same biologic made by different manufacturing processes: An exploratory study with recombinant human growth hormone (rhGH)

Biologicals

Volumn 38, Issue 6, 2010, Pages 637-643

  Cauchy, Mike ^a   Hefford, Mary Alice ^a  

^a HEALTH CANADA   (Canada)

Author keywords

Biosimilars; Comparability; Conformational stability; Excipient exchange; Subsequent entry biologics

Indexed keywords

GLYCINE; HUMAN GROWTH HORMONE; MANNITOL;

ARTICLE; CONCENTRATION (PARAMETERS); CONTROLLED STUDY; DENATURATION; DRUG CONFORMATION; DRUG FORMULATION; DRUG MARKETING; DRUG MIXTURE; DRUG STABILITY; DRUG SYNTHESIS; EXCIPIENT COMPATIBILITY; INTERMETHOD COMPARISON; PRIORITY JOURNAL; REPRODUCIBILITY; THERMOSTABILITY;

EXCIPIENTS; HUMAN GROWTH HORMONE; HUMANS; RECOMBINANT PROTEINS; SPECTROSCOPY, FOURIER TRANSFORM INFRARED;

EID: 78649448511     PISSN: 10451056     EISSN: 10958320     Source Type: Journal    
DOI: 10.1016/j.biologicals.2010.07.005     Document Type: Article

References (46)

1. European Medicines Agency Evaluation of Medicines for Human Use EMEA/CHMP/437/04 guideline on similar biological medicinal products Retrieved from. http://www.ebe-efpia.org/docs/pdf/Biosim_overarching.pdf.
2. Schellekens H. Follow-on biologics: challenges of the " next generation" Nephrology Dialysis Transplantation 2005, 20(Suppl. 4):iv31-iv36.
3. Bouchie A.J. Controversial new biologic approved in US. The Scientist 2006, 20:6.
4. Schellekens H., Moors E. Clinical comparability and European biosimilar regulations. Nature Biotechnology 2010, 28:28-31.
5. Misra A. Are biosimilars really generics?. Expert Opinion on Biological Therapy 2000, 0:1-6.
6. Rathore A.S. Follow-on protein products: scientific issues, developments and challenges. Trends in Biotechnology 2009, 27:698-705.
7. Schellekens H. Biosimilar therapeutics - what do we need to consider?. NDT Plus 2009, 2:i27-i36.
8. European Medicines Agency, Committee for Medicinal Products for Human Use EMEA/CHMP/94526/05 annex guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues - guidance on similar medicinal products containing recombinant erythropoietins (CHMP adopted March 2006). Retrieved from. http://www.emea.eu.int/pdfs/human/biosimilar/9452605en.pdf.
9. European Medicines Agency, Committee for Medicinal Products for Human Use EMEA/CHMP/32775/05 annex guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues - guidance on similar medicinal products containing recombinant human insulin (CHMP adopted February 2006). Retrieved from. http://www.emea.eu.int/pdfs/human/biosimilar/3277505en.pdf.
10. European Medicines Agency, Committee for Medicinal Products for Human Use EMEA/CHMP/31329/05 annex guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues - guidance on biosimilar medicinal products containing recombinant granulocyte-colony stimulating factor (CHMP adopted February 2006). Retrieved from. http://www.emea.eu.int/pdfs/human/biosimilar/3132905en.pdf.
11. European Medicines Agency, Committee for Medicinal Products for Human Use EMEA/CHMP/94528/05 annex guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues - guidance on similar medicinal products containing somatropin (CHMP adopted February 2006). Retrieved from. http://www.emea.eu.int/pdfs/human/biosimilar/9452805en.pdf.
12. Food and Drug Administration 2005. Public workshop: scientific considerations related to developing follow-on protein products, February 14-16, 2005.
13. Health Canada Draft guidance for sponsors: information and submission requirements for subsequent entry biologics (SEBs) and related documents Retrieved from. http://www.hc-sc.gc.ca/dhp-mps/consultation/biolog/2009-03-seb-pbu-eng.p hp%23a1.
14. ®. Journal of Pharmaceutical Sciences 2006, 95:1931-1943.
15. Heavner G.A., Arakawa T., Philo J.S., Calmann M.A., LaBrenz S. Protein isolated from biopharmaceutical formulations cannot be used for comparative studies: follow-up to ldquoa case study using Epoetin Alfa from Epogen and EPREX. Journal of Pharmaceutical Sciences 2007, 96:3214-3225.
16. Park S.S., Park J., Ko J., Chen L., Meriage D., Crouse-Zeineddini J., et al. Biochemical assessment of erythropoietin products from Asia versus US Epoetin alfa manufactured by Amgen. Journal of Pharmaceutical Sciences 2009, 98:1688-1699.
17. Aubin Y., Gingras G., Sauve S. Assessment of the three-dimensional structure of recombinant protein therapeutics by NMR fingerprinting: demonstration on recombinant human granulocyte macrophage-colony stimulation factor. Analytical Chemistry 2008, 80:2623-2627.
18. Lubiniecki A.S., Marcia Federici M. Comparability is not just analytical equivalence. Biologicals 2006, 34:45-47.
19. DeFelippis M.R., Larimore F.S. The role of formulation in insulin comparability assessments. Biologicals 2006, 34:49-54.
20. Bietlot H.P., Girard M. Analysis of recombinant human erythropoietin in drug formulations by high-performance capillary electrophoresis. Journal of Chromatography A 1997, 759:177-184.
21. Izutsu K., Kojima S. Excipient crystallinity and its protein-structure-stabilizing effect during freeze-drying. Journal of Pharmacy and Pharmacology 2002, 54:1033-1039.
22. Pyne A., Chatterjee K., Suryanarayanan R. Solute crystallization in mannitol-glycine systems - implications on protein stabilization in freeze-dried formulations. Journal of Pharmaceutical Sciences 2003, 92:2272-2283.
23. Bam N.B., Cleland J.L., Yang J., Manning M.C., Carpenter J.F., Kelley R.F., et al. Tween protects recombinant human growth hormone against agitation-induced damage via hydrophobic interactions. Journal of Pharmaceutical Sciences 1998, 87:1554-1559.
24. Costantino H.R., Carrasquillo K.G., Cordero R.A., Mumenthaler M., Hsu C.C., Griebenow K. Effect of excipients on the stability and structure of lyophilized recombinant human growth hormone. Journal of Pharmaceutical Sciences 1998, 87:1412-1420.
25. DeFelippis M.R., Alter L.A., Pekar A.H., Havel H.A., Brems D.N. Evidence for a self-associating equilibrium intermediate during folding of human growth hormone. Biochemistry 1993, 32:1555-1562.
26. Eckhardt B.M., Oeswein J.Q., Bewley T.A. Effect of freezing on aggregation of human growth hormone. Pharmaceutical Research 1991, 8:1360-1364.
27. Maa Y.-F., Hsu C.C. Protein denaturation by combined effect of shear and air-liquid interface. Biotechnology and Bioengineering 2000, 54:503-512.
28. Youngman K.M., Spencer D.B., Brems D.N., DeFelippis M.R. Kinetic analysis of the folding of human growth hormone. Influence of disulfide bonds. Jounal of Biological Chemistry 1995, 270:19816-19822.
29. Holzman T.F., Dougherty J.J., Brems D.N., MacKenzie N.E. pH-induced conformational states of bovine growth hormone. Biochemistry 1990, 29:1255-1261.
30. Holzman T.F., Brems D.N., Dougherty J.J. Reoxidation of reduced bovine growth hormone from a stable secondary structure. Biochemistry 1986, 25:6907-6917.
31. Cauchy M., D'aoust S., Dawson B., Rode H., Hefford M.A. Thermal stability: a means to assure tertiary structure in therapeutic proteins. Biologicals 2002, 30:175-185.
32. Ratnaparkhi G.S., Varadarajan R. Osmolytes stabilize ribonuclease s by stabilizing its fragments S protein and S peptide to compact folding-competent states. Journal of Biological Chemistry 2001, 276:28789-28798.
33. Saunders A.J., Davis S., Allen D.L., Pielak G.J., Erie D.A. Osmolyte-induced changes in protein conformational equilibria. Biopolymers 2000, 53:293-307.
34. Bolen D.W., Baskakov I.V. The osmophobic effect: natural selection of a thermodynamic force in protein folding. Journal of Molecular Biology 2001, 310:955-963.
35. Somatotropin, related protein. European pharmacopoeia 2008, European Directorate for the Quality of Medicines and Health Care, Nordlingen, Germany, p. 2932. 6.0 ed.
36. Pace C.N. The stability of globular proteins. Protein structure, a practical approach 1975, 1-43. IRL Press, New York. T. Creighton (Ed.).
37. Creighton T.W. Proteins: structures and molecular properties 1993, W.H. Freeman and Company, New York. 2nd ed.
38. Xie G., Timasheff S.N. Mechanism of the stabilization of ribonuclease A by sorbitol: preferential hydration is greater for the denatured then for the native protein. Protein Science 1997, 6:211-221.
39. Minton A.P. Effect of a concentrated " inert" macromolecular cosolute on the stability of a globular protein with respect to denaturation by heat and by chaotropes: a statistical-thermodynamic model. Biophysical Journal 2000, 78:101-109.
40. Anfinsen C.B. Principles that govern the folding of protein chains. Science 1973, 181:223-230.
41. Kim Y.S., Jones L.S., Dong A., Kendrick B.S., Chang B.S., Manning M.C., et al. Effects of sucrose on conformational equilibria and fluctuations within the native-state ensemble of proteins. Protein Science 2003, 12:1252-1261.
42. Scharnagl C., Reif M., Friedrich J. Stability of proteins: temperature, pressure and the role of the solvent. Biochimica et Biophysica Acta (BBA) - Proteins & Proteomics 2005, 1749:187-213.
43. Franks F. Protein stability: the value of " old literature" Biophysical Chemistry 2002, 96:117-127.
44. Gomez-Orellana I., Variano B., Miura-Fraboni J., Milstein S., Paton D.R. Thermodynamic characterization of an intermediate state of human growth hormone. Protein Science 1998, 7:1352-1358.
45. Peters B., Trout B.L. Asparagine deamidation: pH-dependent mechanism from density functional theory. Biochemistry 2006, 45:5384-5392.
46. Mulinacci F., Bell S.E., Capelle M.A., Gurny R., Arvinte T. Oxidized recombinant human growth hormone that maintains conformational integrity. Journal of Pharmaceutical Sciences Jun 23 2010, [Epub ahead of print].