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Dextrose-mediated aggregation of therapeutic monoclonal antibodies in human plasma: Implication of isoelectric precipitation of complement proteins

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Pages 1094-1103 | Received 07 Jul 2015, Accepted 24 Aug 2015, Published online: 25 Sep 2015

References

  • Langille SE. Particulate matter in injectable drug products. PDA J Pharm Sci Technol 2013; 67:186-200; PMID:23752747; http://dx.doi.org/10.5731/pdajpst.2013.00922
  • Carpenter JF, Randolph TW, Jiskoot W, Crommelin DJ, Middaugh CR, Winter G, Fan YX, Kirshner S, Verthelyi D, Kozlowski S, el al. Overlooking subvisible particles in therapeutic protein products: gaps that may compromise product quality. J Pharm Sci 2009; 98:1201-5; PMID:18704929; http://dx.doi.org/10.1002/jps.21530
  • Wang W, Roberts CJ. Aggregation of Therapeutic Proteins. John Wiley & Sons, Inc; 2010.
  • Rosenberg AS. Effects of protein aggregates: an immunologic perspective. AAPS J 2006; 8:E501-E507; PMID:17025268; http://dx.doi.org/10.1208/aapsj080359
  • Hill SE, Heldman LS, Goo ED, Whippo PE, Perkinson JC. Fatal microvascular pulmonary emboli from precipitation of a total nutrient admixture solution. JPEN J Parenter Enteral Nutr 1996; 20:81-7; PMID:8788269; http://dx.doi.org/10.1177/014860719602000181
  • Jack T, Brent BE, Boehne M, Muller M, Sewald K, Braun A, Wessel A, Sasse M. Analysis of particulate contaminations of infusion solutions in a pediatric intensive care unit. Intensive Care Med 2010; 36:707-11; PMID:20165942; http://dx.doi.org/10.1007/s00134-010-1775-y
  • Boehne M, Jack T, Koditz H, Seidemann K, Schmidt F, Abura M, Bertram H, Sasse M. In-line filtration minimizes organ dysfunction: new aspects from a prospective, randomized, controlled trial. BMC Pediatr 2013; 13:21; PMID:23384207; http://dx.doi.org/10.1186/1471-2431-13-21
  • Jack T, Boehne M, Brent BE, Hoy L, Koditz H, Wessel A, Sasse M. In-line filtration reduces severe complications and length of stay on pediatric intensive care unit: a prospective, randomized, controlled trial. Intensive Care Med 2012; 38:1008-16; PMID:22527062; http://dx.doi.org/10.1007/s00134-012-2539-7
  • Puntis JW, Wilkins KM, Ball PA, Rushton DI, Booth IW. Hazards of parenteral treatment: do particles count? Arch Dis Child 1992; 67:1475-7; PMID:1489228; http://dx.doi.org/10.1136/adc.67.12.1475
  • Shay DK, Fann LM, Jarvis WR. Respiratory distress and sudden death associated with receipt of a peripheral parenteral nutrition admixture. Infect Control Hosp Epidemiol 1997; 18:814-7; PMID:9442405; http://dx.doi.org/10.2307/30141339
  • Bradley JS, Wassel RT, Lee L, Nambiar S. Intravenous ceftriaxone and calcium in the neonate: assessing th10e risk for cardiopulmonary adverse events. Pediatrics 2009; 123:e609-e613; PMID:19289450; http://dx.doi.org/10.1542/peds.2008-3080
  • Cant AJ, Lenney W, Kirkham N. Plastic material from a syringe causing fatal bowel necrosis in a neonate. Br Med J (Clin Res Ed.) 1988; 296:968-9; PMID:3129111; http://dx.doi.org/10.1136/bmj.296.6627.968-a
  • Arvinte T, Palais C, Green-Trexler E, Gregory S, Mach H, Narasimhan C, Shameem M. Aggregation of biopharmaceuticals in human plasma and human serum: implications for drug research and development. mAbs 2013; 5:491-500; PMID:23571158; http://dx.doi.org/10.4161/mabs.24245
  • 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; PMID:20061815; http://dx.doi.org/10.4161/mabs.1.2.7632
  • Peters BJ, Capelle MA, Arvinte T, van de Garde EM. Validation of an automated method for compounding monoclonal antibody patient doses: case studies of Avastin (bevacizumab), Remicade (infliximab) and Herceptin (trastuzumab). mAbs 2013; 5:162-70; PMID:23255057; http://dx.doi.org/10.4161/mabs.22873
  • Janeway CA Jr, Travers P, Walport M, Shlomchik MJ. Immunobiology: The Immune System in Health and Disease. New York: Garland Science; 2001.
  • Soltis RD, Hasz D, Morris MJ, Wilson ID. The effect of heat inactivation of serum on aggregation of immunoglobulins. Immunology 1979; 36:37-45; PMID:422227
  • Miletic VD, Frank MM. Complement-immunoglobulin interactions. Curr Opin Immunol 1995; 7:41-7; PMID:7772281; http://dx.doi.org/10.1016/0952-7915(95)80027-1
  • Harris RJ, Kabakoff B, Macchi FD, Shen FJ, Kwong M, Andya JD, Shire SJ, Bjork N, Totpal K, Chen AB. Identification of multiple sources of charge heterogeneity in a recombinant antibody. J Chromatogr B Biomed Sci Appl 2001; 752:233-45; PMID:11270864; http://dx.doi.org/10.1016/S0378-4347(00)00548-X
  • Moore JM, Patapoff TW, Cromwell ME. Kinetics and thermodynamics of dimer formation and dissociation for a recombinant humanized monoclonal antibody to vascular endothelial growth factor. Biochemistry 1999; 38:13960-7; PMID:10529242; http://dx.doi.org/10.1021/bi9905516
  • Xu Z, Qiu Q, Tian J, Smith JS, Conenello GM, Morita T, Byrnes AP. Coagulation factor X shields adenovirus type 5 from attack by natural antibodies and complement. Nat Med 2013; 19:452-7; PMID:23524342; http://dx.doi.org/10.1038/nm.3107
  • Luo S, Wehr NB, Levine RL. Quantitation of protein on gels and blots by infrared fluorescence of Coomassie blue and Fast Green. Anal Biochem 2006; 350:233-8; PMID:16336940; http://dx.doi.org/10.1016/j.ab.2005.10.048
  • Luo S, Uehara H, Shacter E. Taurine chloramine-induced inactivation of cofilin protein through methionine oxidation. Free Radic Biol Med 2014; 75:84-94; PMID:25058340; http://dx.doi.org/10.1016/j.freeradbiomed.2014.07.018