Glass particles as an adjuvant: A model for adverse immunogenicity of therapeutic proteins

Journal of Pharmaceutical Sciences

Volumn 100, Issue 11, 2011, Pages 4953-4964

  Fradkin, Amber Haynes ^a   Carpenter, John F ^b   Randolph, Theodore W ^a  

^a UCB 450   (United States)

^b UNIVERSITY OF COLORADO   (United States)

Author keywords

High hydrostatic pressure; Immunogenicity; Immunology; Micro flow imaging; Particle size; Protein aggregation; Protein folding refolding; Protein structure; Subvisible particles

Indexed keywords

ALUMINUM; GLASS; GROWTH HORMONE; IMMUNOGLOBULIN G; IMMUNOGLOBULIN G2A; IMMUNOGLOBULIN G2B;

ANIMAL CELL; ANIMAL EXPERIMENT; ARTICLE; CONTROLLED STUDY; ESCHERICHIA COLI; FEMALE; FREEZE THAWING; GEL PERMEATION CHROMATOGRAPHY; HYDROSTATIC PRESSURE; IMMUNE RESPONSE; IMMUNOGENICITY; LIMIT OF DETECTION; MOUSE; NONHUMAN; TREATMENT DURATION; TREATMENT RESPONSE; WEIGHT GAIN;

EID: 80053289158     PISSN: 00223549     EISSN: 15206017     Source Type: Journal    
DOI: 10.1002/jps.22683     Document Type: Article

References (46)

1. Waites MJ, Morgan NL. 2001. Industrial microbiology: An introduction. Malden: Blackwell Science, Inc.
2. Rosenberg AS, Worobec A. 2004. A risk-based approach to immunogenicity concerns of therapeutic protein products, part 1: Considering consequences of the immune response to a protein. Biopharm Int 17(11):22-26.
3. Rosenberg AS. 2006. Effects of protein aggregates: An immunologic perspective. AAPS J 8(3):E501-E507.
4. Hermeling S, Crommelin DJA, Schellekens H, Jiskoot W. 2004. Structure-immunogenicity relationships of therapeutic proteins. Pharm Res 21(6):897-903.
5. Sauerborn M, Brinks V, Jiskoot W, Schellekens H. 2010. Immunological mechanism underlying the immune response to recombinant human protein therapeutics. Trends Pharmacol Sci 31(2):53-59.
6. Li M. 2005. Fatal case of BOTOX-related anaphylaxis? J Forensic Sci 50(1):169-172.
7. Schernthaner G. 1993. Immunogenicity and allergenic potential of animal and human insulins. Diabetes Care 16:155-165.
8. Moss J, Roizen MF, Nordby EJ, Thisted R, Apfelbaum JL, Schreider BD, McDermott DJ. 1985. Decreased incidence and mortality of anaphylaxis to chymopapain. Anesth Analg 64(12):1197-1201.
9. Uversky VN. 2009. Intrinsically disordered proteins and their environment: Effects of strong denaturants, temperature, pH, counter ions, membranes, binding partners, osmolytes, and macromolecular crowding. Protein J 28(7-8):305-325.
10. Hawe A, Kasper JC, Friess W, Jiskoot W. 2009. Structural properties of monoclonal antibody aggregates induced by freeze-thawing and thermal stress. Eur J Pharm Sci 38(2):79-87.
11. Rathore N, Rajan RS. 2008. Current perspectives on stability of protein drug products during formulation, fill and finish operations. Biotechnol Prog 24(3):504-514.
12. Manning MC, Chou DK, Murphy BM, Payne RW, Katayama DS. 2010. Stability of protein pharmaceuticals: An update. Pharm Res 27(4):544-575.
13. Wang W, Nema S, Teagarden D. 2010. Protein aggregation-Pathways and influencing factors. Int J Pharm 390(2):89-99.
14. Fradkin AH, Carpenter JF, Randolph TW. 2009. Immunogenicity of aggregates of recombinant human growth hormone in mouse models. J Pharm Sci 98(9):3247-3264.
15. Koch C, Jensen SS, Oster A, Houen G. 1996. A comparison of the immunogenicity of the native and denatured forms of a protein. APMIS 104(2):115-125.
16. Braun A, Kwee L, Labow MA, Alsenz J. 1997. 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(10):1472-1478.
17. Bee JS, Chiu D, Sawicki S, Stevenson JL, Chatterjee K, Freund E, Carpenter JF, Randolph TW. 2009. Monoclonal antibody interactions with micro- and nanoparticles: Adsorption, aggregation, and accelerated stress studies. J Pharm Sci 98(9):3218-3238.
18. Tyagi AK, Randolph TW, Dong A, Maloney KM, Hitscherich C, Carpenter JF. 2009. IgG particle formation during filling pump operation: A case study of heterogeneous nucleation on stainless steel nanoparticles. J Pharm Sci 98(1):94-104.
19. Chi EY, Weickmann J, Carpenter JF, Manning MC, Randolph TW. 2005. Heterogeneous nucleation-controlled particulate formation of recombinant human platelet-activating factor acetylhydrolase in pharmaceutical formulation. J Pharm Sci 94(2):256-274.
20. Lindblad EB. 2004. Aluminium adjuvants-In retrospect and prospect. Vaccine 22(27-28):3658-3668.
21. Hermeling S, Schellekens H, Maas C, Gebbink M, Crommelin DIA, Jiskoot W. 2006. Antibody response to aggregated human interferon alpha2b in wild-type and transgenic immune tolerant mice depends on type and level of aggregation. J Pharm Sci 95(5):1084-1096.
22. Hermeling S, Aranha L, Damen JMA, Slijper M, Schellekens H, Crommelin DJA, Jiskoot W. 2005. Structural characterization and immunogenicity in wild-type and immune tolerant mice of degraded recombinant human interferon alpha2b. Pharm Res 22(12):1997-2006.
23. Fradkin AH, Boand CS, Eisenberg SP, Rosendahl MS, Randolph TW. 2010. Recombinant murine growth hormone from E. coli inclusion bodies: Expression, high-pressure solubilization and refolding, and characterization of activity and structure. Biotechnol Prog 26(3):743-749.
24. St John RJ, Carpenter JF, Randolph TW. 1999. High pressure fosters protein refolding from aggregates at high concentrations. Proc Natl Acad Sci U S A 96(23):13029-13033.
25. Dong A, Huang P, Caughey WS. 1990. Protein secondary structures in water from second-derivative amide-I infrared-spectra. Biochemistry 29(13):3303-3308.
26. Laboratories CR. 2009. CB6F1 pricing and literature.
27. Dong AC, Jones LS, Kerwin BA, Krishnan S, Carpenter JF. 2006. Secondary structures of proteins adsorbed onto aluminum hydroxide: Infrared spectroscopic analysis of proteins from low solution concentrations. Anal Biochem 351(2):282-289.
28. Yang TH, Dong AC, Meyer J, Johnson OL, Cleland JL, Carpenter JF. 1999. Use of infrared spectroscopy to assess secondary structure of human growth hormone within biodegradable microspheres. J Pharm Sci 88(2):161-165.
29. Fradkin AH, Boand CS, Eisenberg SP, Rosendahl MS, Randolph TW. 2010. Recombinant murine growth hormone from E. coli inclusion bodies: Expression, high-pressure solubilization and refolding, characterization of activity and structure. Biotechnol Prog 26(3):743-749.
30. Sukumar M, Storms SM, De Felippis MR. 2005. Non-native intermediate conformational states of human growth hormone in the presence of organic solvents. Pharm Res 22(5):789-796.
31. Carpenter JF, Randolph TW, Jiskoot W, Crommelin DJA, Middaugh CR, Winter G. 2010. Potential inaccurate quantitation and sizing of protein aggregates by size exclusion chromatography: Essential need to use orthogonal methods to assure the quality of therapeutic protein products. J Pharm Sci 99(5):2200-2208.
32. Carpenter JF, Randolph TW, Jiskoot W, Crommelin DJA, Middaugh CR, Winter G, Fan YX, Kirshner S, Verthelyi D, Kozlowski S, Clouse KA, Swann PG, Rosenberg A, Cherney B. 2009. Overlooking subvisible particles in therapeutic protein products: Gaps that may compromise product quality. J Pharm Sci 98(4):1201-1205.
33. Murphy WJ, Longo DL. 2000. Growth hormone as an immunomodulating therapeutic agent. Immunol Today 21(5):211-213.
34. Redelman D, Welniak LA, Taub D, Murphy WJ. 2008. Neuroendocrine hormones such as growth hormone and prolactin are integral members of the immunological cytokine network. Cell Immunol 252(1-2):111-121.
35. De Gregorio E, D'Oro U, Wack A. 2009. Immunology of TLR-independent vaccine adjuvants. Curr Opin Immunol 21(3):339-345.
36. Jiang BM, Estes MK, Barone C, Barniak V, O'Neal CM, Ottaiano A, Madore HP, Conner ME. 1999. Heterotypic protection from rotavirus infection in mice vaccinated with virus-like particles. Vaccine 17(7-8):1005-1013.
37. Li H, Willingham SB, Ting J, Re F. 2008. Cutting edge: Inflammasome activation by alum and alum's adjuvant effect are mediated by NLRP3. J Immunol 181:17-21.
38. Sacha GA, Saffell-Clemmer W, Abram K, Akers MJ. 2010. Practical fundamentals of glass, rubber, and plastic sterile packaging systems. Pharm Dev Technol 15(1):6-34.
39. Snapper CM, Paul WE. 1987. Interferon-gamma and B-cell stimulatory factor-I reciprocally regulate Ig isotype production. Science 236(4804):944-947.
40. Coutelier JP, Vanderlogt JTM, Heessen FWA, Warnier G, Vansnick J. 1987. Igg2a restriction of murine antibodies elicited by viral-infections. J Exp Med 165(1):64-69.
41. Finkelman FD, Katona IM, Mosmann TR, Coffman RL. 1988. Ifn-gamma regulates the isotypes of Ig secreted during in vivo humoral immune-responses. J Immunol 140(4):1022-1027.
42. Martin RM, Brady JL, Lew AM. 1998. The need for IgG2c specific antiserum when isotyping antibodies from C57BL/6 and NOD mice. J Immunol Methods 212(2):187-192.
43. Rosenberg YJ. 1981. The ability of nonspecific T-cell stimulators to induce helper-cell-dependent increases in either polyclonal or isotype-restricted ig production in vivo. Cell Immunol 61(2):416-424.
44. Teale JM, Abraham KM. 1987. The regulation of antibody class expression. Immunol Today 8(4):122-126.
45. Perlmutter RM, Hansburg D, Briles DE, Nicolotti RA, Davie JM. 1978. Subclass restriction of murine anti-carbohydrate antibodies. J Immunol 121(2):566-572.
46. Snapper CM, McIntyre TM, Mandler R, Pecanha LMT, Finkelman FD, Lees A, Mond JJ. 1992. Induction of Igg3 secretion by interferon gamma-A model for T-cell independent class switching in response to T-Cell independent type-2 antigens. J Exp Med 175(5):1367-1371.