Author

Narendra Chirmule

SymphonyTech Biologics - Cited by 12,102 - Biotherapeutics - Data analytics - Immunology - Drug Development

Biography

Dr. Narendra Chirmule is an Associate professor in the department of laboratory science and biotechnology, Symphony  Tech  Biologics,  Pennsylvania,  USA. His study interests major on emerging or re-emerging disease and the microbes- host interaction. In recent years, he has studied several viruses including HIV-1, human or avian influenza , dengue and Zika viruses.
Title
Cited by
Year
Immunogenicity to therapeutic proteins: impact on PK/PD and efficacy
N Chirmule, V Jawa, B MeibohmThe AAPS journal 14, 296-302, 2012201
294
2012
Highly aggregated antibody therapeutics can enhance the in vitro innate and late-stage T-cell immune responses
MK Joubert, M Hokom, C Eakin, L Zhou, M Deshpande, MP Baker, ...Journal of Biological Chemistry 287 (30), 25266-25279, 2012201
270
2012
Immunogenicity of biotherapeutics: causes and association with posttranslational modifications
A Kuriakose, N Chirmule, P NairJournal of immunology research 2016, 2016201
188
2016
Blockade of interferon‐γ normalizes interferon‐regulated gene expression and serum CXCL10 levels in patients with systemic lupus erythematosus
AA Welcher, M Boedigheimer, AJ Kivitz, Z Amoura, J Buyon, ...Arthritis & rheumatology 67 (10), 2713-2722, 2015201
63
2015
Stratification of antibody-positive subjects by antibody level reveals an impact of immunogenicity on pharmacokinetics
L Zhou, SA Hoofring, Y Wu, T Vu, P Ma, SJ Swanson, N Chirmule, ...The AAPS journal 15, 30-40, 2013201
45
2013
Immunogenicity testing strategy and bioanalytical assays for antibody–drug conjugates
SA Hoofring, R Lopez, MB Hock, A Kaliyaperumal, SK Patel, SJ Swanson, ...Bioanalysis 5 (9), 1041-1055, 2013201
33
2013
Strategic characterization of anti-drug antibody responses for the assessment of clinical relevance and impact
SM Tatarewicz, DT Mytych, MS Manning, SJ Swanson, MS Moxness, ...Bioanalysis 6 (11), 1509-1523, 2014201
30
2014
Detection of anti-ESA antibodies in human samples from PRCA and non-PRCA patients: an immunoassay platform comparison
TE Barger, AJ Kuck, N Chirmule, SJ Swanson, DT MytychNephrology Dialysis Transplantation (2), 688-693, 2012201
27
2012
Measurement of anti-erythropoiesis-stimulating agent IgG4 antibody as an indicator of antibody-mediated pure red cell aplasia
DK Weeraratne, AJ Kuck, N Chirmule, DT MytychClinical and Vaccine Immunology 20 (1), 46-51, 2013201
17
2013
THU0389 a multiple dose study of AMG 811 (Anti-IFN-Gamma) in subjects with systemic lupus erythematosus and active nephritis
DA Martin, Z Amoura, J Romero-Diaz, YB Chong, J Sanchez-Guerrero, ...Annals of the Rheumatic Diseases 74 (Suppl 2), 337-337, 2015201
17
2015
Immune suppression during preclinical drug development mitigates immunogenicity-mediated impact on therapeutic exposure
J Herskovitz, J Ryman, T Thway, S Lee, L Zhou, N Chirmule, B Meibohm, ...The AAPS journal 19, 447-455, 2017201
10
2017
AMG 811 (anti-IFN-gamma) treatment leads to a reduction in the whole blood IFN-signature and serum CXCL10 in subjects with systemic lupus erythematosus: results of two phase I …
AMG 811 (anti-IFN-gamma) treatment leads to a reduction in the whole blood IFN-signature and serum CXCL in subjects with systemic lupus erythematosus: results of two phase I …DA Martin, A Welcher, M Boedigheimer, Z Amoura, A Kivitz, JP Buyon, ...ARTHRITIS AND RHEUMATISM 65, S683-S683, 2013201
10
2013
Development and validation of a cell based assay for the detection of neutralizing antibodies against recombinant insulins
S Chatterjee, L Vashishta, VS Waichale, VG Nayak, R Melarkode, ...Journal of Immunological Methods 452, 53-62, 20120
8
2018
Utility of a bayesian mathematical model to predict the impact of immunogenicity on pharmacokinetics of therapeutic proteins
S Kathman, TM Thway, L Zhou, S Lee, S Yu, M Ma, N Chirmule, V JawaThe AAPS journal 1, 424-431, 2016201
8
2016
CAR-T cell therapy in India requires a paradigm shift in training, education and health care processes
A Ravindranath, A Dubey, S Suresh, G Chaudhuri, N ChirmuleCytotherapy 24 (2), 101-109, 2022202
7
2022
Understanding quality paradigm shifts in the evolving pharmaceutical landscape: perspectives from the USP quality advisory group
J Weitzel, H Pappa, GM Banik, AR Barker, E Bladen, N Chirmule, J DeFeo, ...The AAPS Journal 23, 1-8, 2021202
7
2021
Development and validation of an electrochemiluminescent ELISA for quantitation of oral insulin tregopil in diabetes mellitus serum
SG Ramaswamy, VG Nayak, SK Jha, V Hegde, VS Waichale, ...Bioanalysis 9 (13), 97-986, 2017201
5
2017
Failure Mode and Effects Analysis (FMEA) for Immunogenicity of Therapeutic Proteins
N Chirmule, R Khare, A Khandekar, V JawaJournal of Pharmaceutical Sciences 109 (10), 214-222, 2020202
3
2020
Biopharmaceutical industry capability building in India: report from a symposium
A Uppal, R Chakrabarti, N Chirmule, A Rathore, F AtoufJournal of Pharmaceutical Innovation, 1-8, 2021202
3
2021