Involvement of complement activation in the pulmonary vasoactivity of polystyrene nanoparticles in pigs: unique surface properties underlying alternative pathway activation and instant opsonization

References

• SzebeniJFontanaJLWassefNMHemodynamic changes induced by liposomes and liposome-encapsulated hemoglobin in pigs: a model for pseudoallergic cardiopulmonary reactions to liposomes. Role of complement and inhibition by soluble CR1 and anti-C5a antibodyCirculation199999172302230910226097
   PubMed Web of Science ®Google Scholar
• La-BeckNMGabizonAANanoparticle Interactions with the Immune System: Clinical Implications for Liposome-Based Cancer ChemotherapyFront Immunol2017841628428790
   PubMed Web of Science ®Google Scholar
• SzebeniJMuggiaFGabizonABarenholzYActivation of complement by therapeutic liposomes and other lipid excipient-based therapeutic products: prediction and preventionAdv Drug Deliv Rev201163121020103021787819
   PubMed Web of Science ®Google Scholar
• SzebeniJMuggiaFBarenholzYCase study: Complement activation related hypersensitivity reactions to PEGylated liposomal doxorubicin: Experimental and clinical evidence, mechanisms and approaches to InhibitionDobrovolskaiaMAMcNeilSEHandbook of Immunological Properties of Engineered Nanomaterials2nd edSingaporeWorld Scientific Publishing Company2015331361
   Google Scholar
• SzebeniJStormGComplement activation as a bioequivalence issue relevant to the development of generic liposomes and other nanoparticulate drugsBiochem Biophys Res Commun2015468349049726182876
   PubMed Web of Science ®Google Scholar
• HempelJCPoppelaarsFGaya da CostaMDistinct in vitro Complement Activation by Various Intravenous Iron PreparationsAm J Nephrol2017451495927889746
   PubMed Web of Science ®Google Scholar
• MacdougallICVernonKComplement Activation-Related Pseudo-Allergy: A Fresh Look at Hypersensitivity Reactions to Intravenous IronAm J Nephrol2017451606227894115
   PubMed Web of Science ®Google Scholar
• MoghimiSMNanomedicine safety in preclinical and clinical development: focus on idiosyncratic injection/infusion reactionsDrug Discov Today20182351034104229146517
   PubMed Web of Science ®Google Scholar
• WibroePPAnselmoACNilssonPHBypassing adverse injection reactions to nanoparticles through shape modification and attachment to erythrocytesNat Nanotechnol201712658959428396605
   PubMed Web of Science ®Google Scholar
• SzebeniJMechanism of nanoparticle-induced hypersensitivity in pigs: complement or not complement?Drug Discov Today201823348749229326077
   PubMed Web of Science ®Google Scholar
• Polysciences, IncTechnical datasheet of carboxylated polystyrene nanoparticles2018 Available from:http://www.polysciences.com/default/catalog-products/microspheres-particles/polymer-microspheres/polybead-sup-r-sup-microspheres/polybead-sup-r-sup-functionalized-microspheres/polybead-carboxylAccessed Aug 28 2818
   Google Scholar
• TurjemanKBavliYKizelszteinPNano-Drugs Based on Nano Sterically Stabilized Liposomes for the Treatment of Inflammatory Neurodegenerative DiseasesPLoS One2015107e013044226147975
   PubMed Web of Science ®Google Scholar
• WeiXCohenRBarenholzYInsights into composition/structure/function relationships of Doxil gained from “high-sensitivity” differential scanning calorimetryEur J Pharm Biopharm201610426027027106607
   PubMed Web of Science ®Google Scholar
• BarenholzYAmselemSQuality control assays in the development and clinical use of liposome-based formulationsGregoriadisGLiposome Technology2nd edIBoca Raton, FlCRC Press1993527616
   Google Scholar
• TalmonYTransmission electron microscopy of complex fluids: the state of the artBerichte der Bunsengesellschaft für physikalische Chemie19961003364372
   Google Scholar
• MüllerRHRühlDLückMPaulkeBRInfluence of fluorescent labelling of polystyrene particles on phagocytic uptake, surface hydrophobicity, and plasma protein adsorptionPharm Res199714118249034216
   PubMed Web of Science ®Google Scholar
• UrbanicsRBedőcsPSzebeniJLessons learned from the porcine CARPA model: constant and variable responses to different nano-medicines and administration protocolsEur J Nanomed201573219231
   Google Scholar
• SzebeniJBedőcsPDézsiLUrbanicsRA porcine model of complement activation-related pseudoallergy to nanopharmaceuticals: pros and cons of translation to a preclinical safety testPrec Nanomed201826372
   Google Scholar
• GarbuzenkoOZalipskySQazenMBarenholzYElectrostatics of PEGylated micelles and liposomes containing charged and neutral lipopolymersLangmuir20052162560256815752053
   PubMed Web of Science ®Google Scholar
• FoleyJHPetersonEALeiVWanLWKrisingerMJConwayEMInterplay between fibrinolysis and complement: plasmin cleavage of iC3b modulates immune responsesJ Thromb Haemost20151361061825556624
   PubMed Web of Science ®Google Scholar
• ManningMLWilliamsSAJelinekCAKostovaMBDenmeadeSRProteolysis of complement factors iC3b and C5 by the serine protease prostate-specific antigen in prostatic fluid and seminal plasmaJ Immunol201319062567257423401592
   PubMed Web of Science ®Google Scholar
• Al-HanbaliORuttKJSarkerDKHunterACMoghimiSMConcentration dependent structural ordering of poloxamine 908 on polystyrene nanoparticles and their modulatory role on complement consumptionJ Nanosci Nanotechnol200669–103126313317048527
   PubMed Web of Science ®Google Scholar
• SzebeniJBaranyiLSavaySLiposome-induced pulmonary hypertension: properties and mechanism of a complement-mediated pseudoallergic reactionAm J Physiol20002793H1319H1328
   PubMed Web of Science ®Google Scholar
• SzebeniJBaranyiLSávaySComplement activation-related cardiac anaphylaxis in pigs: role of C5a anaphylatoxin and adenosine in liposome-induced abnormalities in ECG and heart functionAm J Physiol Heart Circ Physiol20062903H1050H105816214844
   PubMed Web of Science ®Google Scholar
• SzebeniJBedocsPRozsnyayZLiposome-induced complement activation and related cardiopulmonary distress in pigs: factors promoting reactogenicity of Doxil and AmBisomeNanomedicine20128217618421704590
   PubMed Web of Science ®Google Scholar
• JackmanJAMészárosTFülöpTUrbanicsRSzebeniJChoNJComparison of complement activation-related pseudoallergy in miniature and domestic pigs: foundation of a validatable immune toxicity modelNanomedicine201612493394326767512
   PubMed Web of Science ®Google Scholar
• RicklinDBarratt-DueAMollnesTEComplement in clinical medicine: Clinical trials, case reports and therapy monitoringMol Immunol201789102128576323
   PubMed Web of Science ®Google Scholar
• Barratt-DueAThorgersenEBEggeKCombined inhibition of complement C5 and CD14 markedly attenuates inflammation, thrombogenicity, and hemodynamic changes in porcine sepsisJ Immunol2013191281982723761634
   PubMed Web of Science ®Google Scholar
• Huber-LangMBarratt-DueAPischkeSEDouble blockade of CD14 and complement C5 abolishes the cytokine storm and improves morbidity and survival in polymicrobial sepsis in miceJ Immunol2014192115324533124790148
   PubMed Web of Science ®Google Scholar
• GustavsenANymoSLandsemACombined Inhibition of Complement and CD14 Attenuates Bacteria-Induced Inflammation in Human Whole Blood More Efficiently Than Antagonizing the Toll-like Receptor 4-MD2 ComplexJ Infect Dis2016214114015026977050
   PubMed Web of Science ®Google Scholar
• DobrovolskaiaMAPre-clinical immunotoxicity studies of nanotechnology-formulated drugs: Challenges, considerations and strategyJ Control Release2015220Pt B57158326348388
   PubMedGoogle Scholar
• PotterTMNeunBWDobrovolskaiaMAIn Vitro and In Vivo Methods for Analysis of Nanoparticle Potential to Induce Delayed-Type Hypersensitivity ReactionsMethods Mol Biol2018168219721029039104
   PubMedGoogle Scholar
• NeunBWIlinskayaANDobrovolskaiaMAAnalysis of Complement Activation by NanoparticlesMethods Mol Biol2018168214916029039100
   PubMedGoogle Scholar
• CedroneENeunBWRodriguezJAnticoagulants influence the performance of in vitro assays intended for characterization of nanotechnology-based formulationsMolecules2018231E12
   Web of Science ®Google Scholar
• ChenFWangGGriffinJIComplement proteins bind to nanoparticle protein corona and undergo dynamic exchange in vivoNat Nanotechnol201712438739327992410
   PubMed Web of Science ®Google Scholar
• FülöpTNemesRMészárosTComplement activation in vitro and reactogenicity of low-molecular weight dextran-coated SPIONs in the pig CARPA model: Correlation with physicochemical features and clinical informationJ Control Release201827026827429203414
   PubMed Web of Science ®Google Scholar
• NewmanSLMikusLKDeposition of C3b and iC3b onto particulate activators of the human complement system. Quantitation with monoclonal antibodies to human C3J Exp Med19851616141414312409200
   PubMed Web of Science ®Google Scholar
• VerbovetskiIBychkovHTrahtembergUOpsonization of apoptotic cells by autologous iC3b facilitates clearance by immature dendritic cells, down-regulates DR and CD86, and up-regulates CC chemokine receptor 7J Exp Med2002196121553156112486098
   PubMed Web of Science ®Google Scholar
• CunnionKMHairPSBuescherESCleavage of complement C3b to iC3b on the surface of Staphylococcus aureus is mediated by serum complement factor IInfect Immun20047252858286315102797
   PubMed Web of Science ®Google Scholar
• SzebeniJBedőcsPUrbanicsRPrevention of infusion reactions to PEGylated liposomal doxorubicin via tachyphylaxis induction by placebo vesicles: a porcine modelJ Control Release2012160238238722421426
   PubMed Web of Science ®Google Scholar
• SzebeniJBedőcsPCsukásDRosivallLBüngerRUrbanicsRA porcine model of complement-mediated infusion reactions to drug carrier nanosystems and other medicinesAdv Drug Deliv Rev201264151706171622820530
   PubMed Web of Science ®Google Scholar
• BaranyiLSzebeniJSavaySComplement-Dependent Shock and Tissue Damage Induced by Intravenous Injection of Cholesterol-Enriched Liposomes in RatsJ Appl Res200333221231
   Google Scholar
• SzebeniJFontanaJLWassefNMLiposome-induced and complement-mediated cardiopulmonary distress in pigs as a model of pseudo-allergic reactions to liposomal drugsMol Immunol1998356–7401
   Web of Science ®Google Scholar
• EMAReflection paper on the data requirements for intravenous liposomal products developed with reference to an innovator liposomal product Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2013/03/WC500140351.pdfAccessed August 28, 2018
   Google Scholar
• FDA/CDER Guidance for IndustryLiposome Drug Products: Chemistry, Manufacturing, and Controls; Human Pharmacokinetics and Bioavailability; and Labeling Documentation Available from: https://www.fda.gov/downloads/drugs/guidances/ucm070570.pdfAccessed August 28, 2018
   Google Scholar