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1

Assessing specificity for immunogenicity assays

Swanson, Steven J, Chirmule, Narendra

Journal:

Year:

2009

Language:

english

File:

PDF, 483 KB

english, 2009

2

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

Tatarewicz, Suzanna M, Mytych, Daniel T, Manning, Marta Starcevic, Swanson, Steven J, Moxness, Michael S, Chirmule, Narendra

Journal:

Year:

2014

Language:

english

File:

PDF, 1.39 MB

english, 2014

3

Immunogenicity testing strategy and bioanalytical assays for antibody–drug conjugates

Hoofring, Sarah A, Lopez, Rocio, Hock, M Benjamin, Kaliyaperumal, Arunan, Patel, Sonal K, Swanson, Steven J, Chirmule, Narendra, Starcevic, Marta

Journal:

Year:

2013

Language:

english

File:

PDF, 1.46 MB

english, 2013

4

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

Herskovitz, Jonathan, Ryman, Josiah, Thway, Theingi, Lee, Stephanie, Zhou, Lei, Chirmule, Narendra, Meibohm, Bernd, Jawa, Vibha

Journal:

The AAPS Journal

Year:

2017

Language:

english

File:

PDF, 1.69 MB

english, 2017

5

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

Chatterjee, Sanjukta, Vashishta, Laxmikant, Waichale, Vinit S., Nayak, Vivek G., Melarkode, Ramakrishnan, Donnelly, Charles M., Vallano, Patrick T., Chirmule, Narendra, Sengupta, Nilanjan

Journal:

Journal of Immunological Methods

Year:

2017

Language:

english

File:

PDF, 785 KB

english, 2017

6

Recommendations for Enhancing Quality and Capability of Indian Biopharmaceutical Industry: Summary of a Workshop

Uppal, Annu, Koduri, Chaitanya Kumar, Yadlapalli, Sireesha, Chirmule, Narendra, Chakrabarti, Ranjan, Atouf, Fouad

Journal:

Journal of Pharmaceutical Sciences

Year:

2020

File:

PDF, 464 KB

2020

7

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

Sarah Bouchard, Tippi C. MacKenzie, Antoneta P. Radu, Satoshi Hayashi, William H. Peranteau, Narendra Chirmule, Alan W. Flake

Journal:

The Journal of Gene Medicine

Year:

2003

Language:

english

File:

PDF, 358 KB

english, 2003

8

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

Olivia Hammond, Yue Wang, Tina Green, Joseph Antonello, Robert Kuhn, Clifford Motley, Philip Stump, Beverly Rich, Narendra Chirmule, Rocio D. Marchese

Journal:

Journal of Medical Virology

Year:

2006

Language:

english

File:

PDF, 251 KB

english, 2006

9

Assessment of immunogenicity of romiplostim in clinical studies with ITP subjects

Vibha Jawa, Martha Hokom, Zheng Hu, Naglaa El-Abaadi, Yao Zhuang, Dietmar Berger, Shalini Gupta, Steven J. Swanson, Narendra Chirmule

Journal:

Annals of Hematology

Year:

2010

Language:

english

File:

PDF, 383 KB

english, 2010

10

Requirement of the T cell receptor for antigen presentation by T lymphocytes. Effect of envelope glycoproteins of HIV-1 on antigen presentation by T cells

N. CHIRMULE, V. S. KALYANARAMAN, H. SLADE, N. OYAIZU, S. PAHWA

Journal:

Clinical & Experimental Immunology

Year:

1990

Language:

english

File:

PDF, 2.17 MB

english, 1990

11

Vβ-Specific Activation of T Cells by the HIV Glycoprotein gp 160

P. N. AKOLKAR, N. CHIRMULE, B. GULWANI-AKOLKAR, S. PAHWA, V. S. KALYANARAMAN, R. PERGOLIZZ, S. MACPHAIL, J. SILVER

Journal:

Scandinavian Journal of Immunology

Year:

1995

Language:

english

File:

PDF, 4.30 MB

english, 1995

12

Influences of related retroviruses on lymphocyte functions

Narendra Chirmule, Carl Saxinger, Savita Pahwa

Journal:

FEMS Microbiology Letters

Year:

1989

Language:

english

File:

PDF, 544 KB

english, 1989

13

Immune responses to adenovirus and adeno-associated virus in humans

Chirmule, N, Propert, K J, Magosin, S A, Qian, Y, Qian, R, Wilson, J M

Journal:

Year:

1999

Language:

english

File:

PDF, 177 KB

english, 1999

14

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

Jooss, K, Chirmule, N

Journal:

Year:

2003

Language:

english

File:

PDF, 145 KB

english, 2003

15

A Step-wise Approach for Transfer of Immunogenicity Assays during Clinical Drug Development

Suzanna Tatarewicz, Michael Moxness, Dohan Weeraratne, Lei Zhou, Michael Hale, Steven J. Swanson, Narendra Chirmule

Journal:

The AAPS Journal

Year:

2009

Language:

english

File:

PDF, 180 KB

english, 2009

16

Comparing Exponentially Weighted Moving Average and Run Rules in Process Control of Semiquantitative Immunogenicity Immunoassays

Troy E. Barger, Lei Zhou, Michael Hale, Michael Moxness, Steven J. Swanson, Narendra Chirmule

Journal:

The AAPS Journal

Year:

2010

Language:

english

File:

PDF, 298 KB

english, 2010

17

Envelope Glycoproteins of HIV-1 Interfere with T-Cell-Dependent B Cell Differentiation: Role of CD4-MHC Class II Interaction in the Effector Phase of T Cell Help

Narendra Chirmule, Xue-Ping Wang, Rong Hu, Naoki Oyaizu, Chaim Roifman, Rajendra Pahwa, Vaniambadi S. Kalyanaraman, Savita Pahwa

Journal:

Cellular Immunology

Year:

1994

File:

PDF, 239 KB

1994

18

The HIV Glycoprotein gp160 Has Superantigen-like Properties

Pradip N. Akolkar, Beena Gulwani-Akolkar, Narendra Chirmule, Savita Pahwa, Vaniambadi S. Kalyanaraman, Robert Pergolizzi, Stuart Macphail, Jack Silver

Journal:

Clinical Immunology and Immunopathology

Year:

1995

File:

PDF, 762 KB

1995

19

Sa.101. Characterization of Immune Thrombocytopenic Purpura (ITP) Patient Sera for Auto Reactivity to TPO Using a Sensitive Biacore Based Biosensor Assay

Vibha Jawa, Martha Hokom, Naglaa El-Abaadi, Jenny Hu, Yao Zhuang, Shalini Gupta, Steven J Swanson, Narendra Chirmule

Journal:

Clinical Immunology

Year:

2008

Language:

english

File:

PDF, 51 KB

english, 2008

20

S.4. Predictive Value of Antibody Concentrations on the Generation of Neutralizing Antibodies to Therapeutic Proteins

Ami Bautista, Hong Han, Francesca Civoli, Shalini Gupta, Steven Swanson, Narendra Chirmule, Vibha Jawa

Journal:

Clinical Immunology

Year:

2009

Language:

english

File:

PDF, 38 KB

english, 2009

21

Early Evaluation of Immunogenicity to a Biotherapeutic by Assessing Antigen-specific T Cells from Whole Blood Derived Peripheral Blood Mononuclear Cells from Cynomolgus Monkeys

Danika Wullner, Dohan Weeraratne, Steven Yu, Kinnari Pandya, Kevin Salyers, Narendra Chirmule, Steven Swanson, Vibha Jawa

Journal:

Clinical Immunology

Year:

2010

Language:

english

File:

PDF, 39 KB

english, 2010

22

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

Danika Wullner, Lei Zhou, Erica Bramhall, Andrew Kuck, Theresa J. Goletz, Steven Swanson, Narendra Chirmule, Vibha Jawa

Journal:

Clinical Immunology

Year:

2010

Language:

english

File:

PDF, 605 KB

english, 2010

23

A novel chemistry for conjugating pneumococcal polysaccharides to Luminex microspheres

Sonela A. Schlottmann, Neil Jain, Narendra Chirmule, Mark T. Esser

Journal:

Journal of Immunological Methods

Year:

2006

Language:

english

File:

PDF, 191 KB

english, 2006

24

Identification and inhibition of drug target interference in immunogenicity assays

Zhandong D. Zhong, Steve Dinnogen, Martha Hokom, Chad Ray, David Weinreich, Steven J. Swanson, Narendra Chirmule

Journal:

Journal of Immunological Methods

Year:

2010

Language:

english

File:

PDF, 963 KB

english, 2010

25

Macrophage ablation attenuates adenoviral vector–induced pancreatitis

Alexander L. Shifrin, Narendra Chirmule, Yi Zhang, Steven E. Raper

Journal:

Year:

2005

Language:

english

File:

PDF, 319 KB

english, 2005

26

PEGylation of E1-Deleted Adenovirus Vectors Allows Significant Gene Expression on Readministration to Liver

Croyle, Maria A., Chirmule, Narendra, Zhang, Yi, Wilson, James M.

Journal:

Human Gene Therapy

Year:

2002

Language:

english

File:

PDF, 792 KB

english, 2002

27

Signals Transduced through the CD4 Molecule on T-Lymphocytes Activate NF-κB

N. Chirmule, V.S. Kalyanaraman, S. Pahwa

Journal:

Biochemical and Biophysical Research Communications

Year:

1994

File:

PDF, 475 KB

1994

28

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

Steven E Raper, Narendra Chirmule, Frank S Lee, Nelson A Wivel, Adam Bagg, Guang-ping Gao, James M Wilson, Mark L Batshaw

Journal:

Molecular Genetics and Metabolism

Year:

2003

Language:

english

File:

PDF, 317 KB

english, 2003

29

Memory T cells and vaccines

Mark T. Esser, Rocio D. Marchese, Lisa S. Kierstead, Lynda G. Tussey, Fubao Wang, Narendra Chirmule, Michael W. Washabaugh

Journal:

Year:

2003

Language:

english

File:

PDF, 251 KB

english, 2003

30

Highly Aggregated Antibody Therapeutics Can Enhance the in Vitro Innate and Late-stage T-cell Immune Responses

Joubert, M. K., Hokom, M., Eakin, C., Zhou, L., Deshpande, M., Baker, M. P., Goletz, T. J., Kerwin, B. A., Chirmule, N., Narhi, L. O., Jawa, V.

Journal:

Journal of Biological Chemistry

Year:

2012

Language:

english

File:

PDF, 2.42 MB

english, 2012

31

Immunogenicity to Therapeutic Proteins: Impact on PK/PD and Efficacy

Narendra Chirmule, Vibha Jawa, Bernd Meibohm

Journal:

The AAPS Journal

Year:

2012

Language:

english

File:

PDF, 187 KB

english, 2012

32

Signals Transduced through the CD4 Molecule Interfere with TCR/CD3-Mediated Ras Activation Leading to T Cell Anergy/Apoptosis

Seetha M.Lakshmi Tamma, Narendra Chirmule, Thomas W. McCloskey, Naoki Oyaizu, V.S. Kalyanaraman, Savita Pahwa

Journal:

Clinical Immunology and Immunopathology

Year:

1997

Language:

english

File:

PDF, 330 KB

english, 1997

33

Misinterpretation of results of cytokine bioassays

Narendra Chirmule, Naoki Oyaizu, Vaniambadi S. Kalyanaraman, Savita Pahwa

Journal:

Journal of Immunological Methods

Year:

1991

Language:

english

File:

PDF, 517 KB

english, 1991

34

Vβ-Specific Activation of T-Cells by the HIV Glycoprotein gp160

PRADIP N. AKOLKAR, BEENA GULWANI-AKOLKAR, NARENDRA CHIRMULE, SAVITA PAHWA, VANIAMBADI S. KALYANARAMAN, ROBERT PERGOLIZZI, STUART MACPHAIL, JACK SILVER

Journal:

Annals of the New York Academy of Sciences

Year:

1995

Language:

english

File:

PDF, 143 KB

english, 1995

35

Influences of related retroviruses on lymphocyte functions

Journal:

FEMS Microbiology Letters

Year:

1989

Language:

english

File:

PDF, 553 KB

english, 1989

36

In vitro Synthesis of Human Immunodeficiency Virus-Specific Antibodies in Peripheral Blood Lymphocytes of Infants

Savita Pahwa, Narendra Chirmule, Corinne Leombruno, Wilma Lim, Rita Harper, Ravi Bhalla, Rajendra Pahwa, Robert P. Nelson and Robert A. Good

Journal:

Proceedings of the National Academy of Sciences

Year:

1989

Language:

english

File:

PDF, 920 KB

english, 1989

37

Stable Transgene Expression in Rod Photoreceptors after Recombinant Adeno-Associated Virus-Mediated Gene Transfer to Monkey Retina

Jean Bennett, Albert M. Maguire, Artur V. Cideciyan, Michael Schnell, Ernest Glover, Vibha Anand, Tomas S. Aleman, Narendra Chirmule, Abha R. Gupta, Yijun Huang, Guang-Ping Gao, William C. Nyberg, Joh

Journal:

Proceedings of the National Academy of Sciences

Year:

1999

Language:

english

File:

PDF, 1.48 MB

english, 1999

38

Statistical and Bioanalytical Considerations for Establishing a Depletion Criterion for Specificity Testing During Immunogenicity Assessment of a Biotherapeutic

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

Journal:

The AAPS Journal

Year:

2013

Language:

english

File:

PDF, 311 KB

english, 2013

39

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, C. E., MacMullen, S. A., Jansen, K. U., Smith, J. F., Chirmule, N., Esser, M. T.

Journal:

Clinical and Vaccine Immunology

Year:

2003

Language:

english

File:

PDF, 474 KB

english, 2003

40

Immunological Characteristics of HIV-Infected Children: Relationship to Age, CD4 Counts, Disease Progression, and Survival

CHIRMULE, NARENDRA, LESSER, MARTIN, GUPTA, ANIL, RAVIPATI, MAHIPAL, KOHN, NINA, PAHWA, SAVITA

Journal:

AIDS Research and Human Retroviruses

Year:

1995

Language:

english

File:

PDF, 1.33 MB

english, 1995

41

Purification of Recombinant Adeno-Associated Virus Vectors by Column Chromatography and Its Performance in Vivo

Gao, Guangping, Qu, Guang, Burnham, Michael S., Huang, James, Chirmule, Narendra, Joshi, Bindu, Yu, Qian-Chun, Marsh, Jonathan A., Conceicao, Christina M., Wilson, James M.

Journal:

Human Gene Therapy

Year:

2000

Language:

english

File:

PDF, 1.30 MB

english, 2000

42

A Phase I Study of Adenovirus-Mediated Transfer of the Human Cystic Fibrosis Transmembrane Conductance Regulator Gene to a Lung Segment of Individuals with Cystic Fibrosis

Zuckerman, Jonathan B., Robinson, Cynthia B., M, Karen S., Shell, Richard, Sferra, Thomas J., Chirmule, Narendra, Magosin, Susan A., Propert, Kathleen J., Brown-Parr, Elsbeth C., Hughes, Joseph V., Ta

Journal:

Human Gene Therapy

Year:

1999

Language:

english

File:

PDF, 753 KB

english, 1999

43

Fas-Fas Ligand Interactions Play a Major Role in Effector Functions of Cytotoxic T Lymphocytes after Adenovirus Vector-Mediated Gene Transfer

Chirmule, Narendra, Moscioni, A. David, Qian, Yinkang, Qian, Ruzheng, Chen, Youhai, Wilson, James M.

Journal:

Human Gene Therapy

Year:

1999

Language:

english

File:

PDF, 548 KB

english, 1999

44

Partial Correction of Murine Hemophilia A with Neo-Antigenic Murine Factor VIII

Sarkar, Rita, Gao, Guang-Ping, Chirmule, Narendra, Tazelaar, John, Kazazian, Haig H.

Journal:

Human Gene Therapy

Year:

2000

Language:

english

File:

PDF, 527 KB

english, 2000

45

Muscle-Specific Promoters May Be Necessary for Adeno-Associated Virus-Mediated Gene Transfer in the Treatment of Muscular Dystrophies

Cordier, Laurence, Gao, Guang-Ping, Hack, Andrew A., McNally, Elizabeth M., Wilson, James M., Chirmule, Narendra, Sweeney, H. Lee

Journal:

Human Gene Therapy

Year:

2001

Language:

english

File:

PDF, 1.43 MB

english, 2001

46

Characterization of the Immune Response After Local Delivery of Recombinant Adenovirus in Murine Pancreas and Successful Strategies for Readministration

McClane, Steven J., Chirmule, Narendra, Burke, Charlotte V., Raper, Steven E.

Journal:

Human Gene Therapy

Year:

1997

Language:

english

File:

PDF, 5.32 MB

english, 1997

47

Superantigen Staphylococcal Enterotoxin B-Induced T-Helper Cell Activation is Independent of CD4 Molecules and Phosphatidylinositol Hydrolysis

Naoki Oyaizu, Narendra Chirmule, Hirosuke Yagura, Rajendra Pahwa, Robert A. Good and Savita Pahwa

Journal:

Proceedings of the National Academy of Sciences

Year:

1992

Language:

english

File:

PDF, 829 KB

english, 1992

48

Development of an Adenovirus-Shedding Assay for the Detection of Adenoviral Vector-Based Vaccine and Gene Therapy Products in Clinical Specimens

Wang, Fubao, Patel, Deepa K., Antonello, Joseph M., Washabaugh, Michael W., Kaslow, David C., Shiver, John W., Chirmule, Narendra

Journal:

Human Gene Therapy

Year:

2003

Language:

english

File:

PDF, 215 KB

english, 2003

49

Adenoviral Vector-Mediated Gene Therapy in the Mouse Lung: No Role of Fas-Fas Ligand Interactions for Elimination of Transgene Expression in Bronchioepithelial Cells

Chirmule, Narendra, Moffett, Jennifer, Dhagat, Parag, Tazelaar, John, Wilson, James M.

Journal:

Human Gene Therapy

Year:

1999

Language:

english

File:

PDF, 790 KB

english, 1999

50

Localization of B-Cell Stimulatory Activity of HIV-1 to the Carboxyl Terminus of gp41

CHIRMULE, NARENDA, KALYANARAMAN, V.S., SAXINGER, CARL, WONG-STAAL, FLOSSIE, GHRAYEB, JOHN, PAHWA, SAVITA

Journal:

AIDS Research and Human Retroviruses

Year:

1990

Language:

english

File:

PDF, 792 KB

english, 1990