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Items: 1 to 50 of 102

1.

Development and validation of a cell based assay for the detection of neutralizing antibodies against recombinant insulins.

Chatterjee S, Vashishta L, Waichale VS, Nayak VG, Melarkode R, Donnelly CM, Vallano PT, Chirmule N, Sengupta N.

J Immunol Methods. 2018 Jan;452:53-62. doi: 10.1016/j.jim.2017.09.004. Epub 2017 Sep 19.

PMID:
28935478
2.

Development and validation of an electrochemiluminescent ELISA for quantitation of oral insulin tregopil in diabetes mellitus serum.

Ramaswamy SG, Nayak VG, Jha SK, Hegde V, Waichale VS, Melarkode R, Chirmule N, Rao AU, Sengupta N.

Bioanalysis. 2017 Jul;9(13):975-986. doi: 10.4155/bio-2017-0020. Epub 2017 Jul 10.

PMID:
28692306
3.

Immune Suppression During Preclinical Drug Development Mitigates Immunogenicity-Mediated Impact on Therapeutic Exposure.

Herskovitz J, Ryman J, Thway T, Lee S, Zhou L, Chirmule N, Meibohm B, Jawa V.

AAPS J. 2017 Mar;19(2):447-455. doi: 10.1208/s12248-016-0026-8. Epub 2017 Jan 9.

PMID:
28070711
4.

Immunogenicity of Biotherapeutics: Causes and Association with Posttranslational Modifications.

Kuriakose A, Chirmule N, Nair P.

J Immunol Res. 2016;2016:1298473. doi: 10.1155/2016/1298473. Epub 2016 Jun 29. Review.

5.

Utility of a Bayesian Mathematical Model to Predict the Impact of Immunogenicity on Pharmacokinetics of Therapeutic Proteins.

Kathman S Jr, Thway TM, Zhou L, Lee S, Yu S, Ma M, Chirmule N, Jawa V.

AAPS J. 2016 Mar;18(2):424-31. doi: 10.1208/s12248-015-9853-2. Epub 2016 Jan 19.

6.

Blockade of interferon-γ normalizes interferon-regulated gene expression and serum CXCL10 levels in patients with systemic lupus erythematosus.

Welcher AA, Boedigheimer M, Kivitz AJ, Amoura Z, Buyon J, Rudinskaya A, Latinis K, Chiu K, Oliner KS, Damore MA, Arnold GE, Sohn W, Chirmule N, Goyal L, Banfield C, Chung JB.

Arthritis Rheumatol. 2015 Oct;67(10):2713-22. doi: 10.1002/art.39248.

7.

Enhancing efficiency and quality of statistical estimation of immunogenicity assay cut points through standardization and automation.

Su C, Zhou L, Hu Z, Weng W, Subramani J, Tadkod V, Hamilton K, Bautista A, Wu Y, Chirmule N, Zhong ZD.

J Immunol Methods. 2015 Oct;425:88-96. doi: 10.1016/j.jim.2015.06.013. Epub 2015 Jun 28. Erratum in: J Immunol Methods. 2015 Dec;427:148.

PMID:
26130368
8.

Strategic characterization of anti-drug antibody responses for the assessment of clinical relevance and impact.

Tatarewicz SM, Mytych DT, Manning MS, Swanson SJ, Moxness MS, Chirmule N.

Bioanalysis. 2014 Jun;6(11):1509-23. doi: 10.4155/bio.14.114. Review. Erratum in: Bioanalysis. 2014;6(14):2020.

PMID:
25046051
9.

Statistical and bioanalytical considerations for establishing a depletion criterion for specificity testing during immunogenicity assessment of a biotherapeutic.

Driscoll RO, Zhou L, Moxness M, Mytych D, Chirmule N, Jawa V.

AAPS J. 2013 Oct;15(4):1160-7. doi: 10.1208/s12248-013-9523-1. Epub 2013 Aug 30.

10.

Immunogenicity testing strategy and bioanalytical assays for antibody-drug conjugates.

Hoofring SA, Lopez R, Hock MB, Kaliyaperumal A, Patel SK, Swanson SJ, Chirmule N, Starcevic M.

Bioanalysis. 2013 May;5(9):1041-55. doi: 10.4155/bio.13.10.

PMID:
23641695
11.

Measurement of anti-erythropoiesis-stimulating agent IgG4 antibody as an indicator of antibody-mediated pure red cell aplasia.

Weeraratne DK, Kuck AJ, Chirmule N, Mytych DT.

Clin Vaccine Immunol. 2013 Jan;20(1):46-51. doi: 10.1128/CVI.00435-12. Epub 2012 Oct 31.

12.

Stratification of antibody-positive subjects by antibody level reveals an impact of immunogenicity on pharmacokinetics.

Zhou L, Hoofring SA, Wu Y, Vu T, Ma P, Swanson SJ, Chirmule N, Starcevic M.

AAPS J. 2013 Jan;15(1):30-40. doi: 10.1208/s12248-012-9408-8. Epub 2012 Oct 9.

13.

Highly aggregated antibody therapeutics can enhance the in vitro innate and late-stage T-cell immune responses.

Joubert MK, Hokom M, Eakin C, Zhou L, Deshpande M, Baker MP, Goletz TJ, Kerwin BA, Chirmule N, Narhi LO, Jawa V.

J Biol Chem. 2012 Jul 20;287(30):25266-79. doi: 10.1074/jbc.M111.330902. Epub 2012 May 14.

14.

Immunogenicity to therapeutic proteins: impact on PK/PD and efficacy.

Chirmule N, Jawa V, Meibohm B.

AAPS J. 2012 Jun;14(2):296-302. doi: 10.1208/s12248-012-9340-y. Epub 2012 Mar 10. Review.

15.

Immunogenicity of panitumumab in combination chemotherapy clinical trials.

Weeraratne D, Chen A, Pennucci JJ, Wu CY, Zhang K, Wright J, Pérez-Ruixo JJ, Yang BB, Kaliyaperumal A, Gupta S, Swanson SJ, Chirmule N, Starcevic M.

BMC Clin Pharmacol. 2011 Nov 9;11:17. doi: 10.1186/1472-6904-11-17.

16.

Detection of anti-ESA antibodies in human samples from PRCA and non-PRCA patients: an immunoassay platform comparison.

Barger TE, Kuck AJ, Chirmule N, Swanson SJ, Mytych DT.

Nephrol Dial Transplant. 2012 Feb;27(2):688-93. doi: 10.1093/ndt/gfr213. Epub 2011 May 19.

PMID:
21602184
17.

Impact of matrix-associated soluble factors on the specificity of the immunogenicity assessment.

Bautista AC, Wullner D, Moxness M, Swanson SJ, Chirmule N, Jawa V.

Bioanalysis. 2010 Apr;2(4):721-31. doi: 10.4155/bio.10.24.

PMID:
21083270
18.

Considerations for optimization and validation of an in vitro PBMC derived T cell assay for immunogenicity prediction of biotherapeutics.

Wullner D, Zhou L, Bramhall E, Kuck A, Goletz TJ, Swanson S, Chirmule N, Jawa V.

Clin Immunol. 2010 Oct;137(1):5-14. doi: 10.1016/j.clim.2010.06.018. Epub 2010 Aug 13.

PMID:
20708973
19.

Identification and inhibition of drug target interference in immunogenicity assays.

Zhong ZD, Dinnogen S, Hokom M, Ray C, Weinreich D, Swanson SJ, Chirmule N.

J Immunol Methods. 2010 Apr 15;355(1-2):21-8. doi: 10.1016/j.jim.2010.02.008. Epub 2010 Feb 24.

PMID:
20188106
20.

Assessment of immunogenicity of romiplostim in clinical studies with ITP subjects.

Jawa V, Hokom M, Hu Z, El-Abaadi N, Zhuang Y, Berger D, Gupta S, Swanson SJ, Chirmule N.

Ann Hematol. 2010 Jul;89 Suppl 1:75-85. Epub 2010 Feb 13.

21.

Comparing exponentially weighted moving average and run rules in process control of semiquantitative immunogenicity immunoassays.

Barger TE, Zhou L, Hale M, Moxness M, Swanson SJ, Chirmule N.

AAPS J. 2010 Mar;12(1):79-86. doi: 10.1208/s12248-009-9166-4. Epub 2009 Dec 10.

22.

A step-wise approach for transfer of immunogenicity assays during clinical drug development.

Tatarewicz S, Moxness M, Weeraratne D, Zhou L, Hale M, Swanson SJ, Chirmule N.

AAPS J. 2009 Sep;11(3):526-34. doi: 10.1208/s12248-009-9130-3. Epub 2009 Jul 22.

23.

Assessing specificity for immunogenicity assays.

Swanson SJ, Chirmule N.

Bioanalysis. 2009 Jun;1(3):611-7. doi: 10.4155/bio.09.41. Review.

PMID:
21083156
24.

Enhanced rates and magnitude of immune responses detected against an HIV vaccine: effect of using an optimized process for isolating PBMC.

Kierstead LS, Dubey S, Meyer B, Tobery TW, Mogg R, Fernandez VR, Long R, Guan L, Gaunt C, Collins K, Sykes KJ, Mehrotra DV, Chirmule N, Shiver JW, Casimiro DR.

AIDS Res Hum Retroviruses. 2007 Jan;23(1):86-92.

PMID:
17263637
25.

The optimization and validation of the glycoprotein ELISA assay for quantitative varicella-zoster virus (VZV) antibody detection.

Hammond O, Wang Y, Green T, Antonello J, Kuhn R, Motley C, Stump P, Rich B, Chirmule N, Marchese RD.

J Med Virol. 2006 Dec;78(12):1679-87.

PMID:
17063506
26.

Enzyme-linked immunosorbent assay for measuring antibodies to pneumococcal polysaccharides for the PNEUMOVAX 23 vaccine: assay operating characteristics and correlation to the WHO international assay.

Marchese RD, Jain NT, Antonello J, Mallette L, Butterfield-Gerson KL, Raab J, Burke P, Schulman C, Adgate H, Sikkema DJ, Chirmule N.

Clin Vaccine Immunol. 2006 Aug;13(8):905-12. Erratum in: Clin Vaccine Immunol. 2008 Jun;15(6):1034.

27.

A novel chemistry for conjugating pneumococcal polysaccharides to Luminex microspheres.

Schlottmann SA, Jain N, Chirmule N, Esser MT.

J Immunol Methods. 2006 Feb 20;309(1-2):75-85. Epub 2006 Jan 6.

PMID:
16448665
28.

Optimization and validation of a multiplexed luminex assay to quantify antibodies to neutralizing epitopes on human papillomaviruses 6, 11, 16, and 18.

Dias D, Van Doren J, Schlottmann S, Kelly S, Puchalski D, Ruiz W, Boerckel P, Kessler J, Antonello JM, Green T, Brown M, Smith J, Chirmule N, Barr E, Jansen KU, Esser MT.

Clin Diagn Lab Immunol. 2005 Aug;12(8):959-69.

29.

Macrophage ablation attenuates adenoviral vector-induced pancreatitis.

Shifrin AL, Chirmule N, Zhang Y, Raper SE.

Surgery. 2005 May;137(5):545-51.

PMID:
15855927
30.

Innate immune responses to adenoviral vector-mediated acute pancreatitis.

Shifrin AL, Chirmule N, Gao GP, Wilson JM, Raper SE.

Pancreas. 2005 Mar;30(2):122-9.

PMID:
15714134
31.
32.

Long-term transgene expression in cardiac and skeletal muscle following fetal administration of adenoviral or adeno-associated viral vectors in mice.

Bouchard S, MacKenzie TC, Radu AP, Hayashi S, Peranteau WH, Chirmule N, Flake AW.

J Gene Med. 2003 Nov;5(11):941-50.

PMID:
14601131
33.

Fatal systemic inflammatory response syndrome in a ornithine transcarbamylase deficient patient following adenoviral gene transfer.

Raper SE, Chirmule N, Lee FS, Wivel NA, Bagg A, Gao GP, Wilson JM, Batshaw ML.

Mol Genet Metab. 2003 Sep-Oct;80(1-2):148-58.

PMID:
14567964
34.

Immunity to adenovirus and adeno-associated viral vectors: implications for gene therapy.

Jooss K, Chirmule N.

Gene Ther. 2003 Jun;10(11):955-63. Review.

PMID:
12756416
35.

Development of an adenovirus-shedding assay for the detection of adenoviral vector-based vaccine and gene therapy products in clinical specimens.

Wang F, Patel DK, Antonello JM, Washabaugh MW, Kaslow DC, Shiver JW, Chirmule N.

Hum Gene Ther. 2003 Jan 1;14(1):25-36.

PMID:
12573056
36.

Memory T cells and vaccines.

Esser MT, Marchese RD, Kierstead LS, Tussey LG, Wang F, Chirmule N, Washabaugh MW.

Vaccine. 2003 Jan 17;21(5-6):419-30. Review.

PMID:
12531640
37.

Simultaneous quantitation of antibodies to neutralizing epitopes on virus-like particles for human papillomavirus types 6, 11, 16, and 18 by a multiplexed luminex assay.

Opalka D, Lachman CE, MacMullen SA, Jansen KU, Smith JF, Chirmule N, Esser MT.

Clin Diagn Lab Immunol. 2003 Jan;10(1):108-15.

38.

PEGylation of E1-deleted adenovirus vectors allows significant gene expression on readministration to liver.

Croyle MA, Chirmule N, Zhang Y, Wilson JM.

Hum Gene Ther. 2002 Oct 10;13(15):1887-900.

PMID:
12396620
39.

A pilot study of in vivo liver-directed gene transfer with an adenoviral vector in partial ornithine transcarbamylase deficiency.

Raper SE, Yudkoff M, Chirmule N, Gao GP, Nunes F, Haskal ZJ, Furth EE, Propert KJ, Robinson MB, Magosin S, Simoes H, Speicher L, Hughes J, Tazelaar J, Wivel NA, Wilson JM, Batshaw ML.

Hum Gene Ther. 2002 Jan 1;13(1):163-75.

PMID:
11779420
40.

Hybrid vectors based on adeno-associated virus serotypes 2 and 5 for muscle-directed gene transfer.

Hildinger M, Auricchio A, Gao G, Wang L, Chirmule N, Wilson JM.

J Virol. 2001 Jul;75(13):6199-203.

41.

Acute cytokine response to systemic adenoviral vectors in mice is mediated by dendritic cells and macrophages.

Zhang Y, Chirmule N, Gao GP, Qian R, Croyle M, Joshi B, Tazelaar J, Wilson JM.

Mol Ther. 2001 May;3(5 Pt 1):697-707.

42.

Biology of E1-deleted adenovirus vectors in nonhuman primate muscle.

Zoltick PW, Chirmule N, Schnell MA, Gao GP, Hughes JV, Wilson JM.

J Virol. 2001 Jun;75(11):5222-9.

44.

Muscle-specific promoters may be necessary for adeno-associated virus-mediated gene transfer in the treatment of muscular dystrophies.

Cordier L, Gao GP, Hack AA, McNally EM, Wilson JM, Chirmule N, Sweeney HL.

Hum Gene Ther. 2001 Jan 20;12(2):205-15.

PMID:
11177557
45.

Purification of recombinant adeno-associated virus vectors by column chromatography and its performance in vivo.

Gao G, Qu G, Burnham MS, Huang J, Chirmule N, Joshi B, Yu QC, Marsh JA, Conceicao CM, Wilson JM.

Hum Gene Ther. 2000 Oct 10;11(15):2079-91.

PMID:
11044910
46.

Route of administration determines induction of T-cell-independent humoral responses to adeno-associated virus vectors.

Xiao W, Chirmule N, Schnell MA, Tazelaar J, Hughes JV, Wilson JM.

Mol Ther. 2000 Apr;1(4):323-9.

48.

Partial correction of murine hemophilia A with neo-antigenic murine factor VIII.

Sarkar R, Gao GP, Chirmule N, Tazelaar J, Kazazian HH Jr.

Hum Gene Ther. 2000 Apr 10;11(6):881-94.

PMID:
10779165
49.

Readministration of adenovirus vector in nonhuman primate lungs by blockade of CD40-CD40 ligand interactions.

Chirmule N, Raper SE, Burkly L, Thomas D, Tazelaar J, Hughes JV, Wilson JM.

J Virol. 2000 Apr;74(7):3345-52.

50.

Additional transduction events after subretinal readministration of recombinant adeno-associated virus.

Anand V, Chirmule N, Fersh M, Maguire AM, Bennett J.

Hum Gene Ther. 2000 Feb 10;11(3):449-57.

PMID:
10697119

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