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Items: 48


Immunogenicity of Protein Pharmaceuticals.

Dingman R, Balu-Iyer SV.

J Pharm Sci. 2019 May;108(5):1637-1654. doi: 10.1016/j.xphs.2018.12.014. Epub 2018 Dec 30. Review.


Sialic Acid-Dependent Inhibition of T Cells by Exosomal Ganglioside GD3 in Ovarian Tumor Microenvironments.

Shenoy GN, Loyall J, Berenson CS, Kelleher RJ Jr, Iyer V, Balu-Iyer SV, Odunsi K, Bankert RB.

J Immunol. 2018 Dec 15;201(12):3750-3758. doi: 10.4049/jimmunol.1801041. Epub 2018 Nov 16.


Subcutaneous administration of Lyso-phosphatidylserine nanoparticles induces immunological tolerance towards Factor VIII in a Hemophilia A mouse model.

Glassman FY, Balu-Iyer SV.

Int J Pharm. 2018 Sep 5;548(1):642-648. doi: 10.1016/j.ijpharm.2018.07.018. Epub 2018 Jul 5.


Phosphatidylserine Is Not Just a Cleanup Crew but Also a Well-Meaning Teacher.

Glassman FY, Schneider JL, Ramakrishnan R, Dingman RK, Ramanathan M, Bankert RB, Balu-Iyer SV.

J Pharm Sci. 2018 Aug;107(8):2048-2054. doi: 10.1016/j.xphs.2018.03.027. Epub 2018 Apr 9.


Challenges and Opportunities for the Subcutaneous Delivery of Therapeutic Proteins.

Turner MR, Balu-Iyer SV.

J Pharm Sci. 2018 May;107(5):1247-1260. doi: 10.1016/j.xphs.2018.01.007. Epub 2018 Jan 11. Review.


Exosomes Associated with Human Ovarian Tumors Harbor a Reversible Checkpoint of T-cell Responses.

Shenoy GN, Loyall J, Maguire O, Iyer V, Kelleher RJ Jr, Minderman H, Wallace PK, Odunsi K, Balu-Iyer SV, Bankert RB.

Cancer Immunol Res. 2018 Feb;6(2):236-247. doi: 10.1158/2326-6066.CIR-17-0113. Epub 2018 Jan 4.


Lipidic Nanoparticles Comprising Phosphatidylinositol Mitigate Immunogenicity and Improve Efficacy of Recombinant Human Acid Alpha-Glucosidase in a Murine Model of Pompe Disease.

Schneider JL, Dingman RK, Balu-Iyer SV.

J Pharm Sci. 2018 Mar;107(3):831-837. doi: 10.1016/j.xphs.2017.10.038. Epub 2017 Nov 2.


Phosphatidylserine Converts Immunogenic Recombinant Human Acid Alpha-Glucosidase to a Tolerogenic Form in a Mouse Model of Pompe Disease.

Schneider JL, Balu-Iyer SV.

J Pharm Sci. 2016 Oct;105(10):3097-3104. doi: 10.1016/j.xphs.2016.06.018. Epub 2016 Jul 31.


Effect of Biophysical Properties of Phosphatidylserine Particle on Immune Tolerance Induction Toward Factor VIII in a Hemophilia A Mouse Model.

Ramakrishnan R, Balu-Iyer SV.

J Pharm Sci. 2016 Oct;105(10):3039-3045. doi: 10.1016/j.xphs.2016.06.008. Epub 2016 Jul 16.


Factor VIII associated with lipidic nanoparticles retains efficacy in the presence of anti-factor VIII antibodies in hemophilia A mice.

Shetty KA, Kosloski MP, Mager DE, Balu-Iyer SV.

Biopharm Drug Dispos. 2016 Oct;37(7):409-420. doi: 10.1002/bdd.2023. Epub 2016 Sep 13.


Soy Phosphatidylinositol-Containing Lipid Nanoparticle Prolongs the Plasma Survival and Hemostatic Efficacy of B-domain-Deleted Recombinant Canine Factor VIII in Hemophilia A Dogs.

Shetty KA, Merricks EP, Raymer R, Rigsbee N, Nichols TC, Balu-Iyer SV.

J Pharm Sci. 2016 Aug;105(8):2459-64. doi: 10.1016/j.xphs.2016.05.023. Epub 2016 Jun 30.


The Effect of Small Oligomeric Protein Aggregates on the Immunogenicity of Intravenous and Subcutaneous Administered Antibodies.

Fathallah AM, Chiang M, Mishra A, Kumar S, Xue L, Russell Middaugh C, Balu-Iyer SV.

J Pharm Sci. 2015 Nov;104(11):3691-3702. doi: 10.1002/jps.24592. Epub 2015 Jul 30.


Exposure of FVIII in the Presence of Phosphatidyl Serine Reduces Generation of Memory B-Cells and Induces Regulatory T-Cell-Mediated Hyporesponsiveness in Hemophilia A Mice.

Ramakrishnan R, Davidowitz A, Balu-Iyer SV.

J Pharm Sci. 2015 Aug;104(8):2451-6. doi: 10.1002/jps.24513. Epub 2015 Jun 2.


Intravenous administration of Factor VIII-O-Phospho-L-Serine (OPLS) complex reduces immunogenicity and preserves pharmacokinetics of the therapeutic protein.

Gaitonde P, Purohit VS, Balu-Iyer SV.

Eur J Pharm Sci. 2015 Jan 23;66:157-62. doi: 10.1016/j.ejps.2014.10.010. Epub 2014 Oct 20.


Anatomical, physiological, and experimental factors affecting the bioavailability of sc-administered large biotherapeutics.

Fathallah AM, Balu-Iyer SV.

J Pharm Sci. 2015 Feb;104(2):301-6. doi: 10.1002/jps.24277. Epub 2014 Nov 19.


Effects of hypertonic buffer composition on lymph node uptake and bioavailability of rituximab, after subcutaneous administration.

Fathallah AM, Turner MR, Mager DE, Balu-Iyer SV.

Biopharm Drug Dispos. 2015 Mar;36(2):115-25. doi: 10.1002/bdd.1925. Epub 2014 Dec 20.


O-phospho-l-serine mediates hyporesponsiveness toward FVIII in hemophilia A-murine model by inducing tolerogenic properties in dendritic cells.

Fathallah AM, Ramakrishnan R, Balu-Iyer SV.

J Pharm Sci. 2014 Nov;103(11):3457-3463. doi: 10.1002/jps.24173. Epub 2014 Sep 29.


Effects of replacement of factor VIII amino acids Asp519 and Glu665 with Val on plasma survival and efficacy in vivo.

Kosloski MP, Shetty KA, Wakabayashi H, Fay PJ, Balu-Iyer SV.

AAPS J. 2014 Sep;16(5):1038-45. doi: 10.1208/s12248-014-9627-2. Epub 2014 Jun 17.


Soy phosphatidylinositol containing nanoparticle prolongs hemostatic activity of B-domain deleted factor VIII in hemophilia A mice.

Shetty KA, Kosloski MP, Mager DE, Balu-Iyer SV.

J Pharm Sci. 2015 Feb;104(2):388-95. doi: 10.1002/jps.23963. Epub 2014 Apr 2.


Nonlinear pharmacokinetics of factor VIII and its phosphatidylinositol lipidic complex in hemophilia A mice.

Kosloski MP, Pisal DS, Mager DE, Balu-Iyer SV.

Biopharm Drug Dispos. 2014 Apr;35(3):154-63. doi: 10.1002/bdd.1880. Epub 2014 Jan 2.


Changes in ovarian tumor cell number, tumor vasculature, and T cell function monitored in vivo using a novel xenograft model.

Yokota SJ, Facciponte JG, Kelleher RJ Jr, Shultz LD, Loyall JL, Parsons RR, Odunsi K, Frelinger JG, Lord EM, Gerber SA, Balu-Iyer SV, Bankert RB.

Cancer Immun. 2013 May 31;13:11. Print 2013.


Immunogenicity of subcutaneously administered therapeutic proteins--a mechanistic perspective.

Fathallah AM, Bankert RB, Balu-Iyer SV.

AAPS J. 2013 Oct;15(4):897-900. doi: 10.1208/s12248-013-9510-6. Epub 2013 Jul 16. Review.


Exposure to factor VIII protein in the presence of phosphatidylserine induces hypo-responsiveness toward factor VIII challenge in hemophilia A mice.

Gaitonde P, Ramakrishnan R, Chin J, Kelleher RJ Jr, Bankert RB, Balu-Iyer SV.

J Biol Chem. 2013 Jun 14;288(24):17051-6. doi: 10.1074/jbc.C112.396325. Epub 2013 May 6.


Allometry of factor VIII and informed scaling of next-generation therapeutic proteins.

Kosloski MP, Pisal DS, Mager DE, Balu-Iyer SV.

J Pharm Sci. 2013 Jul;102(7):2380-94. doi: 10.1002/jps.23566. Epub 2013 Apr 25.


Physicochemical properties of epidermal growth factor receptor inhibitors and development of a nanoliposomal formulation of gefitinib.

Trummer BJ, Iyer V, Balu-Iyer SV, O'Connor R, Straubinger RM.

J Pharm Sci. 2012 Aug;101(8):2763-76. doi: 10.1002/jps.23180. Epub 2012 May 11.


Native-like aggregates of factor VIII are immunogenic in von Willebrand factor deficient and hemophilia a mice.

Pisal DS, Kosloski MP, Middaugh CR, Bankert RB, Balu-Iyer SV.

J Pharm Sci. 2012 Jun;101(6):2055-65. doi: 10.1002/jps.23091. Epub 2012 Mar 2.


PEGylation of a factor VIII-phosphatidylinositol complex: pharmacokinetics and immunogenicity in hemophilia A mice.

Peng A, Kosloski MP, Nakamura G, Ding H, Balu-Iyer SV.

AAPS J. 2012 Mar;14(1):35-42. doi: 10.1208/s12248-011-9309-2. Epub 2011 Dec 16.


Influence of route of administration and liposomal encapsulation on blood and lymph node exposure to the protein VEGF-C156S.

Bhansali SG, Balu-Iyer SV, Morris ME.

J Pharm Sci. 2012 Feb;101(2):852-9. doi: 10.1002/jps.22795. Epub 2011 Oct 26.


Phosphatidylinositol induces fluid phase formation and packing defects in phosphatidylcholine model membranes.

Peng A, Pisal DS, Doty A, Balu-Iyer SV.

Chem Phys Lipids. 2012 Jan;165(1):15-22. doi: 10.1016/j.chemphyslip.2011.10.002. Epub 2011 Oct 17.


Downregulation of CD40 signal and induction of TGF-β by phosphatidylinositol mediates reduction in immunogenicity against recombinant human Factor VIII.

Gaitonde P, Peng A, Straubinger RM, Bankert RB, Balu-Iyer SV.

J Pharm Sci. 2012 Jan;101(1):48-55. doi: 10.1002/jps.22746. Epub 2011 Sep 23.


Humanized mouse model of ovarian cancer recapitulates patient solid tumor progression, ascites formation, and metastasis.

Bankert RB, Balu-Iyer SV, Odunsi K, Shultz LD, Kelleher RJ Jr, Barnas JL, Simpson-Abelson M, Parsons R, Yokota SJ.

PLoS One. 2011;6(9):e24420. doi: 10.1371/journal.pone.0024420. Epub 2011 Sep 15.


Subcutaneous absorption of monoclonal antibodies: role of dose, site of injection, and injection volume on rituximab pharmacokinetics in rats.

Kagan L, Turner MR, Balu-Iyer SV, Mager DE.

Pharm Res. 2012 Feb;29(2):490-9. doi: 10.1007/s11095-011-0578-3. Epub 2011 Sep 2.


Phospholipid binding lowers immunogenicity of human recombinant factor VIII in von Willebrand factor knockout mice.

Pisal DS, Balu-Iyer SV.

Thromb Haemost. 2011 Jun;105(6):1115-8. doi: 10.1160/TH10-09-0628. Epub 2011 Apr 7. No abstract available.


In vitro immunogenicity risk assessment of therapeutic proteins in preclinical setting.

Gaitonde P, Balu-Iyer SV.

Methods Mol Biol. 2011;716:267-80. doi: 10.1007/978-1-61779-012-6_16.


Immunogenicity and pharmacokinetic studies of recombinant factor VIII containing lipid cochleates.

Kosloski MP, Peng A, Varma PR, Fathallah AM, Miclea RD, Mager DE, Balu-iyer SV.

Drug Deliv. 2011 May;18(4):246-54. doi: 10.3109/10717544.2010.536269. Epub 2010 Nov 30.


Phosphatidylserine reduces immune response against human recombinant Factor VIII in Hemophilia A mice by regulation of dendritic cell function.

Gaitonde P, Peng A, Straubinger RM, Bankert RB, Balu-Iyer SV.

Clin Immunol. 2011 Feb;138(2):135-45. doi: 10.1016/j.clim.2010.10.006. Epub 2010 Nov 20.


Phospholipid binding improves plasma survival of factor VIII.

Pisal DS, Balu-Iyer SV.

Thromb Haemost. 2010 Nov;104(5):1073-5. doi: 10.1160/TH10-06-0422. Epub 2010 Sep 13. No abstract available.


Phosphatidylinositol containing lipidic particles reduces immunogenicity and catabolism of factor VIII in hemophilia a mice.

Peng A, Straubinger RM, Balu-Iyer SV.

AAPS J. 2010 Sep;12(3):473-81. doi: 10.1208/s12248-010-9207-z. Epub 2010 Jun 2.


Delivery of therapeutic proteins.

Pisal DS, Kosloski MP, Balu-Iyer SV.

J Pharm Sci. 2010 Jun;99(6):2557-75. doi: 10.1002/jps.22054. Review.


Application of fluorescence spectroscopy to quantify shear-induced protein conformation change.

Themistou E, Singh I, Shang C, Balu-Iyer SV, Alexandridis P, Neelamegham S.

Biophys J. 2009 Nov 4;97(9):2567-76. doi: 10.1016/j.bpj.2009.08.023.


Use of a folding model and in situ spectroscopic techniques for rational formulation development and stability testing of monoclonal antibody therapeutics.

Rao G, Iyer V, Kosloski MP, Pisal DS, Shin E, Middaugh CR, Balu-Iyer SV.

J Pharm Sci. 2010 Apr;99(4):1697-706. doi: 10.1002/jps.21938.


Effect of route of administration of human recombinant factor VIII on its immunogenicity in Hemophilia A mice.

Peng A, Gaitonde P, Kosloski MP, Miclea RD, Varma P, Balu-Iyer SV.

J Pharm Sci. 2009 Dec;98(12):4480-4. doi: 10.1002/jps.21765.


Role of glycosylation in conformational stability, activity, macromolecular interaction and immunogenicity of recombinant human factor VIII.

Kosloski MP, Miclea RD, Balu-Iyer SV.

AAPS J. 2009 Sep;11(3):424-31. doi: 10.1208/s12248-009-9119-y. Epub 2009 Jun 5.


Folding considerations for therapeutic protein formulations.

Korotchkina LG, Ramani K, Balu-Iyer SV.

Prog Mol Biol Transl Sci. 2008;83:255-70. doi: 10.1016/S0079-6603(08)00606-5. No abstract available.


Passive transfer of polyethylene glycol to liposomal-recombinant human FVIII enhances its efficacy in a murine model for hemophilia A.

Ramani K, Purohit V, Miclea R, Gaitonde P, Straubinger RM, Balu-Iyer SV.

J Pharm Sci. 2008 Sep;97(9):3753-64. doi: 10.1002/jps.21266.


Development and characterization of lipidic cochleate containing recombinant factor VIII.

Miclea RD, Varma PR, Peng A, Balu-Iyer SV.

Biochim Biophys Acta. 2007 Nov;1768(11):2890-8. Epub 2007 Aug 19.


O-phospho-L-serine, multi-functional excipient for B domain deleted recombinant factor VIII.

Miclea RD, Purohit VS, Balu-Iyer SV.

AAPS J. 2007 Jun 29;9(2):E251-9.


Phosphatidylserine containing liposomes reduce immunogenicity of recombinant human factor VIII (rFVIII) in a murine model of hemophilia A.

Ramani K, Miclea RD, Purohit VS, Mager DE, Straubinger RM, Balu-Iyer SV.

J Pharm Sci. 2008 Apr;97(4):1386-98.

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