Detection and characterization of subvisible aggregates of monoclonal igg in serum

Pharmaceutical Research

Volumn 29, Issue 8, 2012, Pages 2202-2212

  Filipe, Vasco ^a,b   Poole, Robert ^a   Oladunjoye, Olubukayo ^a   Braeckmans, Kevin ^c,d   Jiskoot, Wim ^a  

^a LEIDEN UNIVERSITY   (Netherlands)

^b UTRECHT UNIVERSITY   (Netherlands)

^c GHENT UNIVERSITY   (Belgium)

^d Centre for Nano and Biophotonics   (Belgium)

Author keywords

Confocal laser scanning microscopy; Flow cytometry; Fluorescence single particle tracking; Monoclonal antibody; Serum; Subvisible protein aggregates

Indexed keywords

BUFFER; IMMUNOGLOBULIN G ANTIBODY;

ARTICLE; CONFOCAL LASER MICROSCOPY; DILUTION; DRUG FORMULATION; FLOW CYTOMETRY; FLUORESCENCE ANALYSIS; HEAT STRESS; IMMUNOGLOBULIN AGGREGATE; INCUBATION TIME; PH; PRIORITY JOURNAL; SERUM;

ANTIBODIES, MONOCLONAL; FLOW CYTOMETRY; FLUORESCENT DYES; HOT TEMPERATURE; HUMANS; HYDROGEN-ION CONCENTRATION; IMMUNOGLOBULIN G; MICROSCOPY, CONFOCAL; PARTICLE SIZE; PROTEIN CONFORMATION; SUCCINIMIDES;

EID: 84864473384     PISSN: 07248741     EISSN: 1573904X     Source Type: Journal    
DOI: 10.1007/s11095-012-0749-x     Document Type: Article

References (41)

1. Cromwell ME, Hilario E, Jacobson F. Protein aggregation and bioprocessing. AAPS J. 2006;8:E572-579.
2. Bee JS, Randolph TW, Carpenter JF, Bishop SM, Dimitrova MN. Effects of surfaces and leachables on the stability of biopharmaceuticals. J Pharm Sci. 2011.
3. Mahler HC, Friess W, Grauschopf U, Kiese S. Protein aggregation: pathways, induction factors and analysis. J Pharm Sci. 2009;98: 2909-34.
4. den Engelsman J, Garidel P, Smulders R, Koll H, Smith B, Bassarab S, et al. Strategies for the assessment of protein aggregates in pharmaceutical biotech product development. Pharm Res. 2011;28:920-33.
5. Rosenberg AS. Effects of protein aggregates: an immunologic perspective. AAPS J. 2006;8:E501-507.
6. Schellekens H. Bioequivalence and the immunogenicity of biopharmaceuticals. Nat Rev Drug Discov. 2002;1:457-62.
7. Hermeling S, Crommelin DJ, Schellekens H, Jiskoot W. Structureimmunogenicity relationships of therapeutic proteins. Pharm Res. 2004;21:897-903.
8. Carpenter JF, Randolph TW, Jiskoot W, Crommelin DJ, Middaugh CR, Winter G, et al. Overlooking subvisible particles in therapeutic protein products: gaps that may compromise product quality. J Pharm Sci. 2009;98:1201-5.
9. Filipe V, Hawe A, Schellekens H, Jiskoot W. Aggregation and immunogenicity of therapeutic proteins. In: Wang W, Roberts CJ, editors. Aggregation of therapeutic proteins. New Jersey: John Wiley & Sons; 2010. p. 403-33.
10. Jiskoot W, van Schie RM, Carstens MG, Schellekens H. Immunological risk of injectable drug delivery systems. Pharm Res. 2009;26:1303-14.
11. Dintzis HM, Dintzis RZ, Vogelstein B. Molecular determinants of immunogenicity: the immunon model of immune response. Proc Natl Acad Sci U S A. 1976;73:3671-5.
12. Hawe A, Kasper JC, Friess W, Jiskoot W. Structural properties of monoclonal antibody aggregates induced by freeze-thawing and thermal stress. Eur J Pharm Sci. 2009;38:79-87.
13. Singh SK, Afonina N, Awwad M, Bechtold-Peters K, Blue JT, Chou D, et al. An industry perspective on the monitoring of subvisible particles as a quality attribute for protein therapeutics. J Pharm Sci. 2010;99:3302-21.
14. Hawe A, Hulse WL, Jiskoot W, RT Forbes. Taylor dispersion analysis compared to dynamic light scattering for the size analysis of therapeutic peptides and proteins and their aggregates. Pharm Res. 2011.
15. Filipe V, Hawe A, Jiskoot W. Critical evaluation of Nanoparticle Tracking Analysis (NTA) by NanoSight for the measurement of nanoparticles and protein aggregates. Pharm Res. 2010;27:796-810.
16. Barnard JG, Singh S, Randolph TW, Carpenter JF. Subvisible particle counting provides a sensitive method of detecting and quantifying aggregation of monoclonal antibody caused by freeze-thawing: insights into the roles of particles in the protein aggregation pathway. J Pharm Sci. 2011;100:492-503.
17. Wuchner K, Buchler J, Spycher R, Dalmonte P, Volkin DB. Development of a microflow digital imaging assay to characterize protein particulates during storage of a high concentration IgG1 monoclonal antibody formulation. J Pharm Sci. 2010;99:3343-61.
18. Demeule B, Shire SJ, Liu J. A therapeutic antibody and its antigen form different complexes in serum than in phosphate-buffered saline: a study by analytical ultracentrifugation. Anal Biochem. 2009;388:279-87.
19. Braeckmans K, Buyens K, Bouquet W, Vervaet C, Joye P, De Vos F, et al. Sizing nanomatter in biological fluids by fluorescence single particle tracking. Nano Lett. 2010;10:4435-42.
20. Filipe V, Poole R, Kutscher M, Forier K, Braeckmans K, Jiskoot W. Fluorescence single particle tracking for the characterization of submicron protein aggregates in biological fluids and complex formulations. Pharm Res. 2011;28:1112-20.
21. Mach H, Bhambhani A, Meyer BK, Burek S, Davis H, Blue JT, et al. The use of flow cytometry for the detection of subvisible particles in therapeutic protein formulations. J Pharm Sci. 2011; 100:1671-8.
22. Tamerler C, Sarikaya M. Genetically designed Peptide-based molecular materials. ACS Nano. 2009;3:1606-15.
23. Odom TW, Nehl CL. How gold nanoparticles have stayed in the light: the 3M's principle. ACS Nano. 2008;2:612-6.
24. van Beers MM, Sauerborn M, Gilli F, Brinks V, Schellekens H, Jiskoot W. Aggregated recombinant human interferon Beta induces antibodies but no memory in immune-tolerant transgenic mice. Pharm Res. 2010;27:1812-24.
25. Seale K, Janetopoulos C, Wikswo J. Micro-mirrors for nanoscale three-dimensional microscopy. ACS Nano. 2009;3:493-7.
26. Philo JS. A critical review of methods for size characterization of non-particulate protein aggregates. Curr Pharm Biotechnol. 2009;10:359-72.
27. Peyrin-Biroulet L, Laclotte C, Bigard MA. Adalimumab maintenance therapy for Crohn's disease with intolerance or lost response to infliximab: an open-label study. Aliment Pharmacol Ther. 2007;25:675-80.
28. Shealy D, Cai A, Staquet K, Baker A, Lacy ER, Johns L, et al. Characterization of golimumab, a human monoclonal antibody specific for human tumor necrosis factor alpha. MAbs. 2010;2.
29. Chumsae C, Gaza-Bulseco G, Liu H. Identification and localization of unpaired cysteine residues in monoclonal antibodies by fluorescence labeling and mass spectrometry. Anal Chem. 2009; 81:6449-57.
30. Wang W, Nema S, Teagarden D. Protein aggregation-pathways and influencing factors. Int J Pharm. 2010;390:89-99.
31. Zhao J, Xu D, Zhang K, Cheng X. Quantum chemical study of C-SH bond dissociation energies for some thiol compounds. Comp Theor Chem. 2009;909:9-12.
32. Alvarez B, Ferrer-Sueta G, Freeman BA, Radi R. Kinetics of peroxynitrite reaction with amino acids and human serum albumin. J Biol Chem. 1999;274:842-8.
33. Volkin DB, Middaugh CR. Vaccines as physically and chemically well-defined pharmaceutical dosage forms. Expert Rev Vaccine. 2010;9:689-91.
34. Crandall RE, Janatova J, Andrade JD. The effects of radioiodination and fluorescent labelling on albumin. Prep Biochem. 1981;11: 111-38.
35. Wang W, Li N, Speaker S. External factors affecting protein aggregation. In: Wang W, Roberts CJ, editors. Aggregation of therapeutic proteins. New Jersey: John Wiley & Sons; 2010. p. 119-204.
36. Luo Q, Joubert MK, Stevenson R, Ketchem RR, Narhi LO, Wypych J. Chemical modifications in therapeutic protein aggregates generated under different stress conditions. J Biol Chem. 2011.
37. Philo JS. Is any measurement method optimal for all aggregate sizes and types? AAPS J. 2006;8:E564-571.
38. Aggarwal P, Hall JB, McLeland CB, Dobrovolskaia MA, McNeil SE. Nanoparticle interaction with plasma proteins as it relates to particle biodistribution, biocompatibility and therapeutic efficacy. Adv Drug Deliv Rev. 2009;61:428-37.
39. Turner MW, Hulme B. The plasma proteins: an introduction. London: Pitman Medical & Scientific Publishing; 1970.
40. Augener W, Grey HM, Cooper NR, Muller-Eberhard HJ. The reaction of monomeric and aggregated immunoglobulins with C1. Immunochemistry. 1971;8:1011-20.
41. Ziccardi RJ, Cooper NR. The subunit composition and sedimentation properties of human C1. J Immunol. 1977;118:2047-52.