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Volumn 101, Issue 10, 2012, Pages 3568-3579

Protein particles: What we know and what we do not know

Author keywords

Biopharmaceuticals characterization; Imaging methods; Light scattering; Microparticles; Nanoparticles; Particle size; Physical characterization; Protein aggregation

Indexed keywords

FLUORESCENT DYE; MONOCLONAL ANTIBODY; MONOMER; POLYSTYRENE; PROTEIN; SURFACTANT;

EID: 84865378494     PISSN: 00223549     EISSN: 15206017     Source Type: Journal    
DOI: 10.1002/jps.23242     Document Type: Note
Times cited : (92)

References (47)
  • 3
    • 68949132582 scopus 로고    scopus 로고
    • Quantitation of protein particles in parenteral solutions using micro-flow imaging
    • Huang C-T, Sharma D, Oma P, Krishnamurthy R. 2009. Quantitation of protein particles in parenteral solutions using micro-flow imaging. J Pharm Sci 98:3058-3071.
    • (2009) J Pharm Sci , vol.98 , pp. 3058-3071
    • Huang, C.-T.1    Sharma, D.2    Oma, P.3    Krishnamurthy, R.4
  • 4
    • 69249206868 scopus 로고    scopus 로고
    • A critical review of methods for size characterization of non-particulate protein aggregates
    • Philo, JS. 2009. A critical review of methods for size characterization of non-particulate protein aggregates. Curr Pharm Biotechnol 10:359-372.
    • (2009) Curr Pharm Biotechnol , vol.10 , pp. 359-372
    • Philo, J.S.1
  • 6
    • 33646546740 scopus 로고    scopus 로고
    • Antibody response to aggregated human interferon alpha2b in wild-type and transgenic immune tolerant mice depends on type and level of aggregation
    • Hermeling S, Schellekens H, Maas C, Gebbink MF, Crommelin DJ, 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. 95:1084-1096.
    • (2006) J Pharm Sci. , vol.95 , pp. 1084-1096
    • Hermeling, S.1    Schellekens, H.2    Maas, C.3    Gebbink, M.F.4    Crommelin, D.J.5    Jiskoot, W.6
  • 7
    • 33748041958 scopus 로고    scopus 로고
    • Effects of protein aggregates: An immunologic perspective
    • Rosenberg AS. 2006. Effects of protein aggregates: An immunologic perspective. AAPS J 8:E501-E507.
    • (2006) AAPS J , vol.8
    • Rosenberg, A.S.1
  • 8
    • 68949135230 scopus 로고    scopus 로고
    • Immunogenicity of aggregates of recombinant human growth hormone in mouse models
    • Fradkin AH, Carpenter JF, Randolph TW. 2009. Immunogenicity of aggregates of recombinant human growth hormone in mouse models. J Pharm Sci 98:3247-3264.
    • (2009) J Pharm Sci , vol.98 , pp. 3247-3264
    • Fradkin, A.H.1    Carpenter, J.F.2    Randolph, T.W.3
  • 12
    • 77949821607 scopus 로고    scopus 로고
    • Protein adsorption and excipient effects on kinetic stability of silicone oil emulsions
    • Ludwig DB, Carpenter JF, Hamel JB, Randolph TW. 2010. Protein adsorption and excipient effects on kinetic stability of silicone oil emulsions. J Pharm Sci 99:1721-1733.
    • (2010) J Pharm Sci , vol.99 , pp. 1721-1733
    • Ludwig, D.B.1    Carpenter, J.F.2    Hamel, J.B.3    Randolph, T.W.4
  • 13
    • 79960128166 scopus 로고    scopus 로고
    • Classification and characterization of therapeutic antibody aggregates
    • Joubert MK, Luo Q, Nashed-Samuel Y, Wypych J, Narhi LO. 2011. Classification and characterization of therapeutic antibody aggregates. J Biol Chem 286:25118-25133.
    • (2011) J Biol Chem , vol.286 , pp. 25118-25133
    • Joubert, M.K.1    Luo, Q.2    Nashed-Samuel, Y.3    Wypych, J.4    Narhi, L.O.5
  • 14
    • 77949789023 scopus 로고    scopus 로고
    • High throughput thermostability screening of monoclonal antibody formulations
    • He F, Hogan S, Latypov RF, Narhi LO, Razinkov VI. 2010. High throughput thermostability screening of monoclonal antibody formulations. J Pharm Sci 99:1707-1720.
    • (2010) J Pharm Sci , vol.99 , pp. 1707-1720
    • He, F.1    Hogan, S.2    Latypov, R.F.3    Narhi, L.O.4    Razinkov, V.I.5
  • 16
    • 0342762048 scopus 로고    scopus 로고
    • Protein denaturation by combined effect of shear and air-liquid interface.
    • Maa Y-F, Hsu CC. 1997. Protein denaturation by combined effect of shear and air-liquid interface. Biotechnol Bioeng 54:503-512.
    • (1997) Biotechnol Bioeng , vol.54 , pp. 503-512
    • Maa, Y.-F.1    Hsu, C.C.2
  • 19
    • 58149216346 scopus 로고    scopus 로고
    • IgG particle formation during filling pump operation: A case study of heterogeneous nucleation on stainless steel nanoparticles
    • Tyagi AK, Randolph TW, Dong A, Maloney KM, Hitscherich C Jr, Carpenter JF. 2009. IgG particle formation during filling pump operation: A case study of heterogeneous nucleation on stainless steel nanoparticles. J Pharm Sci 98:94-104.
    • (2009) J Pharm Sci , vol.98 , pp. 94-104
    • Tyagi, A.K.1    Randolph, T.W.2    Dong, A.3    Maloney, K.M.4    Hitscherich Jr., C.5    Carpenter, J.F.6
  • 20
    • 80052265031 scopus 로고    scopus 로고
    • Characterization of subvisible particle formation during the filling pump operation of a monoclonal antibody solution
    • Nayak A, Colandene J, Bradford V, Perkins M. 2011. Characterization of subvisible particle formation during the filling pump operation of a monoclonal antibody solution. J Pharm Sci 100:4198-4204.
    • (2011) J Pharm Sci , vol.100 , pp. 4198-4204
    • Nayak, A.1    Colandene, J.2    Bradford, V.3    Perkins, M.4
  • 21
    • 74049118384 scopus 로고    scopus 로고
    • Equilibrium studies of protein aggregates and homogeneous nucleation in protein formulation
    • Kiese S, Pappenberger A, Friess W, Mahler H-C. 2010. Equilibrium studies of protein aggregates and homogeneous nucleation in protein formulation. J Pharm Sci 99:632-644.
    • (2010) J Pharm Sci , vol.99 , pp. 632-644
    • Kiese, S.1    Pappenberger, A.2    Friess, W.3    Mahler, H.-C.4
  • 22
    • 77955101936 scopus 로고    scopus 로고
    • Development of a microflow digital imaging assay to characterize protein particulates during storage of a high concentration IgG1 monoclonal antibody formulation
    • Wuchner K, Büchler J, Spycher R, Dalmonte P, Volkin DB. 2010. Development of a microflow digital imaging assay to characterize protein particulates during storage of a high concentration IgG1 monoclonal antibody formulation. J Pharm Sci 99:3343-3361.
    • (2010) J Pharm Sci , vol.99 , pp. 3343-3361
    • Wuchner, K.1    Büchler, J.2    Spycher, R.3    Dalmonte, P.4    Volkin, D.B.5
  • 23
    • 33646217549 scopus 로고
    • Moment and Fokker-Planck equations for the growth and decay of small objects.
    • Clement CF, Wood MH. 1980. Moment and Fokker-Planck equations for the growth and decay of small objects. Proc. R Soc Lond A 371:553-567.
    • (1980) Proc. R Soc Lond A , vol.371 , pp. 553-567
    • Clement, C.F.1    Wood, M.H.2
  • 24
    • 0021851611 scopus 로고
    • Surface geometry irregularity of particulate materials: The fractal approach
    • Avnir D, Farin D, Pfeifer P. 1985. Surface geometry irregularity of particulate materials: The fractal approach. J Colloid Interface Sci 103:112-123.
    • (1985) J Colloid Interface Sci , vol.103 , pp. 112-123
    • Avnir, D.1    Farin, D.2    Pfeifer, P.3
  • 25
    • 10144232149 scopus 로고    scopus 로고
    • Prediction of three-dimensional fractal dimensions using the two-dimensional properties of fractal aggregates
    • Lee C, Kramer TA. 2004. Prediction of three-dimensional fractal dimensions using the two-dimensional properties of fractal aggregates. Adv Colloid Interface Sci 112:49-57.
    • (2004) Adv Colloid Interface Sci , vol.112 , pp. 49-57
    • Lee, C.1    Kramer, T.A.2
  • 26
    • 80052586089 scopus 로고    scopus 로고
    • Standards for the optical detection of protein particles
    • Ripple D, Wayment JR, Carrier MJ. 2010. Standards for the optical detection of protein particles. Am Pharm Rev 14:90-96.
    • (2010) Am Pharm Rev , vol.14 , pp. 90-96
    • Ripple, D.1    Wayment, J.R.2    Carrier, M.J.3
  • 27
    • 2542516405 scopus 로고    scopus 로고
    • The density and refractive index of adsorbing protein layers
    • Vörös J. 2004. The density and refractive index of adsorbing protein layers. Biophys J 87:553-561.
    • (2004) Biophys J , vol.87 , pp. 553-561
    • Vörös, J.1
  • 28
    • 0030977640 scopus 로고    scopus 로고
    • Immunons revisited: Binding of multivalent antigens to B cells
    • Sulzer B, Perelson AS. 1997. Immunons revisited: Binding of multivalent antigens to B cells. Mol Immunol 34:63-74.
    • (1997) Mol Immunol , vol.34 , pp. 63-74
    • Sulzer, B.1    Perelson, A.S.2
  • 29
    • 84860242762 scopus 로고    scopus 로고
    • The pathway of cross-presentation is influenced by the particle size of phagocytosed antigen
    • Mant A, Chinnery F, Elliott T, Williams AP. 2012. The pathway of cross-presentation is influenced by the particle size of phagocytosed antigen. Immunology 136:163-175.
    • (2012) Immunology , vol.136 , pp. 163-175
    • Mant, A.1    Chinnery, F.2    Elliott, T.3    Williams, A.P.4
  • 30
    • 7044274793 scopus 로고    scopus 로고
    • Aluminium compounds for use in vaccines
    • Lindblad EB. 2004. Aluminium compounds for use in vaccines. Immunol Cell Biol 82:497-505.
    • (2004) Immunol Cell Biol , vol.82 , pp. 497-505
    • Lindblad, E.B.1
  • 32
    • 84865388068 scopus 로고    scopus 로고
    • USP/NF General Chapter <788>. Particulate matter in injections
    • US Pharmacopeia. Rockville, Maryland: USP.
    • US Pharmacopeia. 2007. USP/NF General Chapter <788>. Particulate matter in injections. In US Pharmacopeia, National Formulary, USP31-NF-26. Rockville, Maryland: USP.
    • (2007) US Pharmacopeia, National Formulary, USP31-NF-26
  • 33
    • 0001410173 scopus 로고
    • Particle size measurement: The equivalent spherical diameter
    • Jennings BR, Parslow K. 1988. Particle size measurement: The equivalent spherical diameter. Proc R S Lond A 419:137-149.
    • (1988) Proc R S Lond A , vol.419 , pp. 137-149
    • Jennings, B.R.1    Parslow, K.2
  • 34
    • 69249213763 scopus 로고    scopus 로고
    • Separation and characterization of protein aggregates and particles by field flow fractionation
    • Cao S, Pollastrini J, Jiang Y. 2009. Separation and characterization of protein aggregates and particles by field flow fractionation. Curr Pharm Biotechnol 10:382-390.
    • (2009) Curr Pharm Biotechnol , vol.10 , pp. 382-390
    • Cao, S.1    Pollastrini, J.2    Jiang, Y.3
  • 35
    • 77953291167 scopus 로고    scopus 로고
    • Critical evaluation of nanoparticle tracking analysis (NTA) by NanoSight for the measurement of nanoparticles and protein aggregates
    • Filipe V, Hawe A, Jiskoot W. 2010. Critical evaluation of nanoparticle tracking analysis (NTA) by NanoSight for the measurement of nanoparticles and protein aggregates. Pharm Res 27:796-810.
    • (2010) Pharm Res , vol.27 , pp. 796-810
    • Filipe, V.1    Hawe, A.2    Jiskoot, W.3
  • 36
    • 77955933028 scopus 로고    scopus 로고
    • Micro-flow imaging: Flow microscopy applied to sub-visible particulate analysis in protein formulations
    • Sharma DK, King D, Oma P, Merchant C. 2010. Micro-flow imaging: Flow microscopy applied to sub-visible particulate analysis in protein formulations. AAPS J 12:455-464.
    • (2010) AAPS J , vol.12 , pp. 455-464
    • Sharma, D.K.1    King, D.2    Oma, P.3    Merchant, C.4
  • 37
    • 84875590267 scopus 로고    scopus 로고
    • Rapid assessment of aggregates in protein-based pharmaceuticals. Poster presentation at AAPS National Biotechnology Conference, May 16-19, 2010; San Francisco, California (accessed at
    • Dai L, Coleman J, Shen D, Pande P, Patton WF. 2010. Rapid assessment of aggregates in protein-based pharmaceuticals. Poster presentation at AAPS National Biotechnology Conference, May 16-19, 2010; San Francisco, California (accessed at http://www.enzolifesciences.com/fileadmin/files/poster/ZZ_Sc0510_1012_AAPS_FINAL_A3.pdf).
    • (2010)
    • Dai, L.1    Coleman, J.2    Shen, D.3    Pande, P.4    Patton, W.F.5
  • 38
    • 79952218924 scopus 로고    scopus 로고
    • The use of flow cytometry for the detection of subvisible particles in therapeutic protein formulations
    • Mach H, Bhambhani A, Meyer BK, Burek S, Davis H, Blue JT, Evans RK. 2011. The use of flow cytometry for the detection of subvisible particles in therapeutic protein formulations. J Pharm Sci 100:1671-1678.
    • (2011) J Pharm Sci , vol.100 , pp. 1671-1678
    • Mach, H.1    Bhambhani, A.2    Meyer, B.K.3    Burek, S.4    Davis, H.5    Blue, J.T.6    Evans, R.K.7
  • 39
    • 79551519898 scopus 로고    scopus 로고
    • Flow cytometry: A promising technique for the study of silicone oil-induced particulate formation in protein formulations
    • Ludwig DB, Trotter JT, Gabrielson JP, Carpenter JF, Randolph TW. 2011. Flow cytometry: A promising technique for the study of silicone oil-induced particulate formation in protein formulations. Anal Biochem 410:191-199.
    • (2011) Anal Biochem , vol.410 , pp. 191-199
    • Ludwig, D.B.1    Trotter, J.T.2    Gabrielson, J.P.3    Carpenter, J.F.4    Randolph, T.W.5
  • 40
    • 79959387984 scopus 로고    scopus 로고
    • Development of multicolor flow cytometry calibration standards: Assignment of equivalent reference fluorophores (ERF) unit
    • Wang L, Gaigalas AK. 2011. Development of multicolor flow cytometry calibration standards: Assignment of equivalent reference fluorophores (ERF) unit. J Res Natl Inst Stand Technol 116:671-683.
    • (2011) J Res Natl Inst Stand Technol , vol.116 , pp. 671-683
    • Wang, L.1    Gaigalas, A.K.2
  • 41
    • 78649661342 scopus 로고    scopus 로고
    • Characterization of particles in protein solutions: Reaching the limits of current technologies
    • Demeule B, Messick S, Shire SJ, Liu J. 2010. Characterization of particles in protein solutions: Reaching the limits of current technologies. AAPS J 12:708-715.
    • (2010) AAPS J , vol.12 , pp. 708-715
    • Demeule, B.1    Messick, S.2    Shire, S.J.3    Liu, J.4
  • 42
    • 82255174991 scopus 로고    scopus 로고
    • Critical evaluation and guidance for using the coulter method for counting subvisible particles in protein solutions
    • Barnard JG, Rhyner MN, Carpenter JF. 2012. Critical evaluation and guidance for using the coulter method for counting subvisible particles in protein solutions. J Pharm Sci 101:140-153.
    • (2012) J Pharm Sci , vol.101 , pp. 140-153
    • Barnard, J.G.1    Rhyner, M.N.2    Carpenter, J.F.3
  • 43
    • 79955605394 scopus 로고    scopus 로고
    • Fluorescence single particle tracking for the characterization of submicron protein aggregates in biological fluids and complex formulations
    • Filipe V, Poole R, Kutscher M, Forier K, Braeckmans K, Jiskoot W. 2011. Fluorescence single particle tracking for the characterization of submicron protein aggregates in biological fluids and complex formulations. Pharm Res 28:1112-1120.
    • (2011) Pharm Res , vol.28 , pp. 1112-1120
    • Filipe, V.1    Poole, R.2    Kutscher, M.3    Forier, K.4    Braeckmans, K.5    Jiskoot, W.6
  • 45
    • 69249215475 scopus 로고    scopus 로고
    • A critical review of analytical methods for subvisible and visible particles
    • Narhi LO, Jiang Y, Cao S, Benedek K, Shnek D. 2009. A critical review of analytical methods for subvisible and visible particles. Curr Pharm Biotechnol 10:373-381.
    • (2009) Curr Pharm Biotechnol , vol.10 , pp. 373-381
    • Narhi, L.O.1    Jiang, Y.2    Cao, S.3    Benedek, K.4    Shnek, D.5
  • 46
    • 69249209980 scopus 로고    scopus 로고
    • Application of vibrational spectroscopy to the structural characterization of monoclonal antibody and its aggregate
    • Li CH, Li T. 2009. Application of vibrational spectroscopy to the structural characterization of monoclonal antibody and its aggregate. Curr Pharm Biotechnol 10:391-399.
    • (2009) Curr Pharm Biotechnol , vol.10 , pp. 391-399
    • Li, C.H.1    Li, T.2
  • 47
    • 84860581906 scopus 로고    scopus 로고
    • Distinct aggregation mechanisms of monoclonal antibody under thermal and freeze-thaw stresses revealed by hydrogen exchange
    • Zhang A, Singh SK, Shirts MR, Kumar S, Fernandez EJ. 2012. Distinct aggregation mechanisms of monoclonal antibody under thermal and freeze-thaw stresses revealed by hydrogen exchange. Pharm Res 29:236-250.
    • (2012) Pharm Res , vol.29 , pp. 236-250
    • Zhang, A.1    Singh, S.K.2    Shirts, M.R.3    Kumar, S.4    Fernandez, E.J.5


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