Search Results - "Shankar, Gopi"

A generic method for the detection of polyethylene glycol specific IgG and IgM antibodies in human serum by Ehlinger, Christopher, Spear, Nathan, Doddareddy, Rajitha, Shankar, Gopi, Schantz, Allen

“…Detection of anti-drug antibodies is a critical step in the development of large molecule biopharmaceuticals. In the case of multicomponent/multifunctional…”
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A risk-based bioanalytical strategy for the assessment of antibody immune responses against biological drugs by Shankar, Gopi, Pendley, Charles, Stein, Kathryn E

“…Bioanalytical assessments of anti-drug antibodies (ADAs) provide an understanding of the immunogenicity of biological drug molecules. The potential to induce…”
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Recommendations for the validation of immunoassays used for detection of host antibodies against biotechnology products by Shankar, Gopi, Devanarayan, Viswanath, Amaravadi, Lakshmi, Barrett, Yu Chen, Bowsher, Ronald, Finco-Kent, Deborah, Fiscella, Michele, Gorovits, Boris, Kirschner, Susan, Moxness, Michael, Parish, Thomas, Quarmby, Valerie, Smith, Holly, Smith, Wendell, Zuckerman, Linda A., Koren, Eugen

“…Most biological drug products elicit some level of anti-drug antibody (ADA) response. This antibody response can, in some cases, lead to potentially serious…”
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Detection of low-affinity anti-drug antibodies and improved drug tolerance in immunogenicity testing by Octet ® biolayer interferometry by Li, Jian, Schantz, Allen, Schwegler, Maureen, Shankar, Gopi

“…We assessed the utility of the FortéBio Octet ® system for detection of anti-drug antibodies (ADAs) against an investigational therapeutic human IgG1…”
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Therapeutic targeting of the IL-12/23 pathways: generation and characterization of ustekinumab by Benson, Jacqueline M, Sachs, Clifford W, Treacy, George, Zhou, Honghui, Pendley, Charles E, Brodmerkel, Carrie M, Shankar, Gopi, Mascelli, Mary A

“…Preclinical and clinical studies conducted in the mid-1990s reported strong association and causality between the T-cell helper (T H ) 1 inductor cytokine…”
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Role of bronchoscopy and imaging in long-standing foreign body bronchus presenting as recurrent or non-resolving lower respiratory tract infection by Agrawal, Shailesh Ramesh, Gopi Shankar, S., Joshi, Anagha A., Patekar, Shivali, Bradoo, Renuka A.

“…Introduction A long-standing retained foreign body in the bronchus is unusual. In majority of cases, an adequate history is not obtained, the clinical picture…”
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Immunogenicity of biologically-derived therapeutics: Assessment and interpretation of nonclinical safety studies by Ponce, Rafael, Abad, Leslie, Amaravadi, Lakshmi, Gelzleichter, Thomas, Gore, Elizabeth, Green, James, Gupta, Shalini, Herzyk, Danuta, Hurst, Christopher, Ivens, Inge A., Kawabata, Thomas, Maier, Curtis, Mounho, Barbara, Rup, Bonita, Shankar, Gopi, Smith, Holly, Thomas, Peter, Wierda, Dan

“…An evaluation of potential antibody formation to biologic therapeutics during the course of nonclinical safety studies and its impact on the toxicity profile…”
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Recommendations for the design and optimization of immunoassays used in the detection of host antibodies against biotechnology products by Mire-Sluis, Anthony R, Barrett, Yu Chen, Devanarayan, Viswanath, Koren, Eugen, Liu, Hank, Maia, Mauricio, Parish, Thomas, Scott, George, Shankar, Gopi, Shores, Elizabeth, Swanson, Steven J, Taniguchi, Gary, Wierda, Daniel, Zuckerman, Linda A

“…Most biopharmaceutical therapeutics elicit some level of antibody response against the product. This antibody response can, in some cases, lead to potentially…”
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“AIR LEAK SYNDROME”: An Unusual Presentation of Foreign Body in the Airway by Velecharla, Madhu Sudhan, Shah, Kshitij Dhaval, Bradoo, Renuka Anil, Subramaniasami, Gopi Shankar, Joshi, Anagha Atul

“…Spontaneous onset pneumomediastinum, pneumothorax and subcutaneous emphysema are rare presentations of a foreign body in the airway. The possible mechanism for…”
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Tetraselmis indica Mediated Green Synthesis of Zinc Oxide (ZnO) Nanoparticles and Evaluating Its Antibacterial, Antioxidant, and Hemolytic Activity by Thirumoorthy, Gopi Shankar, Balasubramaniam, Oviyashri, Kumaresan, Punitha, Muthusamy, Poongothai, Subramani, Karthik

“…The indenture of the green approach in synthesizing metal oxide nanoparticles has resulted in greater stoutness and favorable dimensions of nanoparticles since…”
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Lack of Racial Differences in the Pharmacokinetics of Subcutaneous Golimumab in Healthy Japanese and Caucasian Male Subjects by Ling, Jie, Lyn, Sally, Xu, Zhenhua, Achira, Meguru, Bouman-Thio, Esther, Shishido, Akira, Ford, Joyce, Shankar, Gopi, Wagner, Carrie, Kim, Kenneth T., Davis, Hugh M., Zhou, Honghui

“…This phase 1 study evaluated the single‐dose pharmacokinetics and safety of subcutaneous golimumab, a human anti—tumor necrosis factor‐α monoclonal antibody,…”
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Current challenges in assessing immunogenicity by Shankar, Gopi

“…Gopi Shankar is a Vice President at Janssen BioTherapeutics, the biotechnology discovery and development unit of Janssen Research & Development, LLC (one of…”
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“AIR LEAK SYNDROME”: An Unusual Presentation of Foreign Body in the Airway by Velecharla, Madhu Sudhan, Shah, Kshitij Dhaval, Bradoo, Renuka Anil, Subramaniasami, Gopi Shankar, Joshi, Anagha Atul

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Idiopathic pneumonia syndrome after bone marrow transplantation: the role of pre-transplant radiation conditioning and local cytokine dysregulation in promoting lung inflammation and fibrosis by Shankar, Gopi, Cohen, Donald A.

“…Pulmonary complications and graft‐vs.‐host disease (GVHD) remain severe threats to survival after bone marrow transplantation (BMT). Idiopathic pneumonia…”
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Interferon-gamma Added During Bacillus Calmette-Guerin Induced Dendritic Cell Maturation Stimulates Potent Th1 Immune Responses by Shankar, Gopi, Pestano, Linda A, Bosch, Marnix L

“…Dendritic cells (DC) are increasingly prepared in vitro for use in immunotherapy trials. Mature DC express high levels of surface molecules needed for T cell…”
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Immunogenicity of golimumab and its clinical relevance in patients with rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis by Leu, Jocelyn H, Adedokun, Omoniyi J, Gargano, Cynthia, Hsia, Elizabeth C, Xu, Zhenhua, Shankar, Gopi

“…Abstract Objective Golimumab immunogenicity was extensively studied during clinical development. As anti-drug antibody (ADA) detection with the standard…”
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P049 COMPARISON OF USTEKINUMAB CONCENTRATION ASSAYS AND ANTIBODIES-TO-USTEKINUMAB ASSAYS by Marini, Joseph C., Chun, Kelly Y., Rebarchak, Shannon, Dogmanits, Shannon, Sloan, Sheldon, Shankar, Gopi

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The challenge of indication extrapolation for infliximab biosimilars by Feagan, Brian G., Choquette, Denis, Ghosh, Subrata, Gladman, Dafna D., Ho, Vincent, Meibohm, Bernd, Zou, Guangyong, Xu, Zhenhua, Shankar, Gopi, Sealey, David C., Russell, Anthony S.

“…A biosimilar is intended to be highly similar to a reference biologic such that any differences in quality attributes (i.e., molecular characteristics) do not…”
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P049 COMPARISON OF USTEKINUMAB CONCENTRATION ASSAYS AND ANTIBODIES-TO-USTEKINUMAB ASSAYS by Marini, Joseph C, Chun, Kelly Y, Rebarchak, Shannon, Dogmanits, Shannon, Sloan, Sheldon, Shankar, Gopi

“…Abstract Background Monitoring ustekinumab (UST) concentrations and antibodies-to ustekinumab (ATU) during IBD treatment may allow more informed decisions in…”
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Development of a Method That Eliminates False-Positive Results due to Nerve Growth Factor Interference in the Assessment of Fulranumab Immunogenicity by Dai, Sheng, Schantz, Allen, Clements-Egan, Adrienne, Cannon, Michael, Shankar, Gopi

“…Fulranumab, a human IgG2 monoclonal antibody that neutralizes nerve growth factor (NGF), is currently in development for the treatment of pain. Our initial…”
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