Aggregation of biopharmaceuticals in human plasma and human serum

References

• Schellekens H. Immunogenicity of therapeutic proteins: clinical implications and future prospects. Clin Ther 2002; 24:1720 - 40, discussion 1719; http://dx.doi.org/10.1016/S0149-2918(02)80075-3; PMID: 12501870
   PubMed Web of Science ®Google Scholar
• Schellekens H. Bioequivalence and the immunogenicity of biopharmaceuticals. Nat Rev Drug Discov 2002; 1:457 - 62; http://dx.doi.org/10.1038/nrd818; PMID: 12119747
   PubMed Web of Science ®Google Scholar
• Macdougall IC. Epoetin-induced pure red cell aplasia: diagnosis and treatment. Curr Opin Nephrol Hypertens 2007; 16:585 - 8; http://dx.doi.org/10.1097/MNH.0b013e3282f0c4bf; PMID: 18089975
   PubMed Web of Science ®Google Scholar
• Schellekens H, Jiskoot W. Erythropoietin-associated PRCA: still an unsolved mystery. J Immunotoxicol 2006; 3:123 - 30; http://dx.doi.org/10.1080/15476910600845567; PMID: 18958692
   PubMedGoogle Scholar
• Chennamsetty N, Voynov V, Kayser V, Helk B, Trout BL. Prediction of aggregation prone regions of therapeutic proteins. J Phys Chem B 2010; 114:6614 - 24; http://dx.doi.org/10.1021/jp911706q; PMID: 20411962
   PubMed Web of Science ®Google Scholar
• Koren E, De Groot AS, Jawa V, Beck KD, Boone T, Rivera D, et al. Clinical validation of the “in silico” prediction of immunogenicity of a human recombinant therapeutic protein. Clin Immunol 2007; 124:26 - 32; http://dx.doi.org/10.1016/j.clim.2007.03.544; PMID: 17490912
   PubMed Web of Science ®Google Scholar
• 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; http://dx.doi.org/10.1002/jps.22097; PMID: 20310025
   PubMed Web of Science ®Google Scholar
• Carpenter JF, Randolph TW, Jiskoot W, Crommelin DJA, 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; http://dx.doi.org/10.1002/jps.21530; PMID: 18704929
   PubMed Web of Science ®Google Scholar
• Saluja A, Kalonia DS. Nature and consequences of protein-protein interactions in high protein concentration solutions. Int J Pharm 2008; 358:1 - 15; http://dx.doi.org/10.1016/j.ijpharm.2008.03.041; PMID: 18485634
   PubMed Web of Science ®Google Scholar
• Mahler HC, Friess W, Grauschopf U, Kiese S. Protein aggregation: pathways, induction factors and analysis. J Pharm Sci 2009; 98:2909 - 34; http://dx.doi.org/10.1002/jps.21566; PMID: 18823031
   PubMed Web of Science ®Google Scholar
• Kanai S, Liu J, Patapoff TW, Shire SJ. Reversible self-association of a concentrated monoclonal antibody solution mediated by Fab-Fab interaction that impacts solution viscosity. J Pharm Sci 2008; 97:4219 - 27; http://dx.doi.org/10.1002/jps.21322; PMID: 18240303
   PubMed Web of Science ®Google Scholar
• Demeule B, Palais C, Machaidze G, Gurny R, Arvinte T. New methods allowing the detection of protein aggregates: a case study on trastuzumab. MAbs 2009; 1:142 - 50; http://dx.doi.org/10.4161/mabs.1.2.7632; PMID: 20061815
   PubMed Web of Science ®Google Scholar
• Demeule B, Gurny R, Arvinte T. Detection and characterization of protein aggregates by fluorescence microscopy. Int J Pharm 2007; 329:37 - 45; http://dx.doi.org/10.1016/j.ijpharm.2006.08.024; PMID: 17005340
   PubMed Web of Science ®Google Scholar
• Demeule B, Lawrence MJ, Drake AF, Gurny R, Arvinte T. Characterization of protein aggregation: the case of a therapeutic immunoglobulin. Biochim Biophys Acta 2007; 1774:146 - 53; http://dx.doi.org/10.1016/j.bbapap.2006.10.010; PMID: 17142116
   PubMed Web of Science ®Google Scholar
• Harn N, Spitznagel T, Perkins M, Allan C, Shire S, Middaugh CR. Biophysical signatures of monoclonal antibodies. Biotechnology Pharmaceutical Aspects 2010; 11:229 - 46
   Google Scholar
• Liu J, Nguyen MDH, Andya JD, Shire SJ. Reversible self-association increases the viscosity of a concentrated monoclonal antibody in aqueous solution. J Pharm Sci 2005; 94:1928 - 40; http://dx.doi.org/10.1002/jps.20347; PMID: 16052543
   PubMed Web of Science ®Google Scholar
• Saluja A, Kalonia DS. Measurement of fluid viscosity at microliter volumes using quartz impedance analysis. AAPS PharmSciTech 2004; 5:e47; http://dx.doi.org/10.1208/pt050347; PMID: 15760080
   PubMedGoogle Scholar
• Volkin DB, Mach H, Middaugh CR. Degradative covalent reactions important to protein stability. Mol Biotechnol 1997; 8:105 - 22; http://dx.doi.org/10.1007/BF02752255; PMID: 9406181
   PubMed Web of Science ®Google Scholar
• Capelle MAH, Gurny R, Arvinte T. High throughput screening of protein formulation stability: practical considerations. Eur J Pharm Biopharm 2007; 65:131 - 48; http://dx.doi.org/10.1016/j.ejpb.2006.09.009; PMID: 17107777
   PubMed Web of Science ®Google Scholar
• 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; http://dx.doi.org/10.1016/j.ab.2009.03.012; PMID: 19289095
   PubMed Web of Science ®Google Scholar
• Filipe V, Poole R, Oladunjoye O, Braeckmans K, Jiskoot W. Detection and characterization of subvisible aggregates of monoclonal IgG in serum. Pharm Res 2012; 29:2202 - 12; http://dx.doi.org/10.1007/s11095-012-0749-x; PMID: 22467219
   PubMed Web of Science ®Google Scholar
• Herceptin®, Avastin® and Remicade® prescribing information. US Food and Drug Administration www.accessdata.fda.gov/scripts/cder/drugsatfda/
   Google Scholar
• Neupogen® prescribing information. US Food and Drug Administration www.accessdata.fda.gov/scripts/cder/drugsatfda/
   Google Scholar
• USP home page: http://www.usp.org/; search “<788<Particulate Matter in Injections” or document m99586-gc_788-1.pdf.
   Google Scholar
• Malmqvist M, Karlsson R. Biomolecular interaction analysis: affinity biosensor technologies for functional analysis of proteins. Curr Opin Chem Biol 1997; 1:378 - 83; http://dx.doi.org/10.1016/S1367-5931(97)80077-4; PMID: 9667873
   PubMed Web of Science ®Google Scholar
• Karlsson R, Kullman-Magnusson M, Hämäläinen MD, Remaeus A, Andersson K, Borg P, et al. Biosensor analysis of drug-target interactions: direct and competitive binding assays for investigation of interactions between thrombin and thrombin inhibitors. Anal Biochem 2000; 278:1 - 13; http://dx.doi.org/10.1006/abio.1999.4406; PMID: 10640347
   PubMed Web of Science ®Google Scholar
• Roos H, Karlsson R, Nilshans H, Persson A. Thermodynamic analysis of protein interactions with biosensor technology. J Mol Recognit 1998; 11:204 - 10; http://dx.doi.org/10.1002/(SICI)1099-1352(199812)11:1/6<204::AID-JMR424>3.0.CO;2-T; PMID: 10076841
   PubMed Web of Science ®Google Scholar
• Humira® prescribing information. AbbVie. www.rxabbott.com/u4_prescribing_info.cfm
   Google Scholar
• George TJ Jr., Laplant KD, Walden EO, Davis AB, Riggs CE, Close JL, et al. Managing cetuximab hypersensitivity-infusion reactions: incidence, risk factors, prevention, and retreatment. J Support Oncol 2010; 8:72 - 7; PMID: 20464886
   PubMedGoogle Scholar
• Garvan JM, Gunner BW. The harmful effects of particles in intravenous fluids. Med J Aust 1964; 2:1 - 6; PMID: 14175312
   PubMedGoogle Scholar
• Franke RP. Quantifizierung partikuläre Baustanteile in der Mikrozirkulation der Lunge. Beitr Elektronenmikroskop Dirrektabb Oberfl 1986; 19:429 - 34
   Google Scholar
• Avastin® prescribing information: www.roche.fr/fmfiles/re7199006/notices/avastin/Avastin25mg-ml10132500MAJ08-08-11.pdf
   Google Scholar
• Paraplatin® and Taxol® prescribing information: packageinserts.bms.com/pi/pi_paraplatin.pdf packageinserts.bms.com/pi/pi_taxol.pdf.
   Google Scholar
• Platinol® prescribing information. US Food and Drug Administration www.accessdata.fda.gov/scripts/cder/drugsatfda/
   Google Scholar
• FDA. “Important Drug Warning” Letter to Genentech, January 5, 2005 on the “increased risk of arterial thromboembolic events associated with the use of AVASTINTM (Bevacizumab) in combination with chemotherapy.” see: www.fda.gov/downloads/Safety/MedWatch/SafetyInformation/ SafetyAlertsforHumanMedicalProducts/UCM164188.pdf and www.fda.gov/Safety/MedWatch/SafetyInformation/ SafetyAlertsforHumanMedicalProducts/ucm150721.htm.
   Google Scholar
• Hurwitz HI, Saltz LB, Van Cutsem E, Cassidy J, Wiedemann J, Sirzén F, et al. Venous thromboembolic events with chemotherapy plus bevacizumab: a pooled analysis of patients in randomized phase II and III studies. J Clin Oncol 2011; 29:1757 - 64; http://dx.doi.org/10.1200/JCO.2010.32.3220; PMID: 21422411
   PubMed Web of Science ®Google Scholar