Search Results - "Gunn, George R"

Recommendations for the validation of cell-based assays used for the detection of neutralizing antibody immune responses elicited against biological therapeutics by Gupta, Shalini, Devanarayan, Viswanath, Finco, Deborah, Gunn, George R., Kirshner, Susan, Richards, Susan, Rup, Bonita, Song, An, Subramanyam, Meena

“…The administration of biological therapeutics may result in the development of anti-drug antibodies (ADAs) in treated subjects. In some cases, ADA responses…”
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Immunogenicity of Golimumab and its Clinical Relevance in Patients With Ulcerative Colitis by Adedokun, Omoniyi J, Gunn, George R, Leu, Jocelyn H, Gargano, Cynthia, Xu, Zhenhua, Sandborn, William J, Rutgeerts, Paul, Shankar, Gopi

“…Antidrug antibody (ADA) detection with standard bridging enzyme immunoassays (EIA) can yield false-negative results or underestimate titers through drug…”
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Characterization of the robust humoral immune response to GSK2618960, a humanized anti-IL-7 receptor monoclonal antibody, observed in healthy subjects in a Phase 1 study by Liao, Karen, Chen, Keguan, Brett, Sara, Gehman, Andrew, Schwartz, Ann M, Gunn, George R, DeWall, Stephen L

“…Interleukin-7 (IL-7) signaling modulates T cell activity and is implicated in numerous autoimmune diseases. An anti-IL-7 receptor monoclonal antibody…”
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Recombinant Listeria vaccines containing PEST sequences are potent immune adjuvants for the tumor-associated antigen human papillomavirus-16 E7 by SEWELL, Duane A, SHAHABI, Vafa, GUNN, George R, PAN, Zhen-Kun, DOMINIECKI, Mary E, PATERSON, Yvonne

“…Previous work in our laboratory has established that the fusion of tumor-associated antigens to a truncated form of the Listeria monocytogenes virulence factor…”
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Determination of label efficiency and label degree of critical reagents by LC-MS and native MS by Carle, Katie, Kellie, John F., Gunn, George R., Jiang, Yong

“…Degree of labeling and label efficiency are key factors for optimal characterization of critical reagents that are used in ligand binding assays. Here, three…”
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Comparison of competitive ligand-binding assay and bioassay formats for the measurement of neutralizing antibodies to protein therapeutics by Finco, Deborah, Baltrukonis, Daniel, Clements-Egan, Adrienne, Delaria, Kathy, Gunn, George R., Lowe, John, Maia, Mauricio, Wong, Teresa

“…Administration of biological therapeutic proteins can lead to unwanted immunogenicity in recipients of these products. The assessment and characterization of…”
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Report on the AAPS Immunogenicity Guidance Forum by Myler, Heather, Gorovits, Boris, Phillips, Kelli, Devanarayan, Viswanath, Clements-Egan, Adrienne, Gunn, George R., Kirshner, Susan, DeSilva, Binodh, Shah, Vinod P.

“…In September 2018, the American Association of Pharmaceutical Scientists (AAPS) conducted an Annual Guidance Forum on the considerations related to…”
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Anti-drug Antibody Validation Testing and Reporting Harmonization by Myler, Heather, Pedras-Vasconcelos, João, Phillips, Kelli, Hottenstein, Charles Scott, Chamberlain, Paul, Devanaryan, Viswanath, Gleason, Carol, Goodman, Joanne, Manning, Marta Starcevic, Purushothama, Shobha, Richards, Susan, Shen, Honglue, Zoghbi, Jad, Amaravadi, Lakshmi, Barger, Troy, Bowen, Steven, Bowsher, Ronald R., Clements-Egan, Adrienne, Geng, Dong, Goletz, Theresa J., Gunn, George R., Hallett, William, Hodsdon, Michael E., Janelsins, Brian M., Jawa, Vibha, Kamondi, Szilard, Kirshner, Susan, Kramer, Daniel, Liang, Meina, Lindley, Kathryn, Liu, Susana, Liu, ZhenZhen, McNally, Jim, Mikulskis, Alvydas, Nelson, Robert, Ahbari, Mohsen Rajabi, Qu, Qiang, Ruppel, Jane, Snoeck, Veerle, Song, An, Yan, Haoheng, Ware, Mark

“…Evolving immunogenicity assay performance expectations and a lack of harmonized anti-drug antibody validation testing and reporting tools have resulted in…”
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Immunogenicity and biomarkers: bioanalytical challenges and considerations by Gunn, George R, Evans, Christopher, Yang, Eric

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2020 White Paper on Recent Issues in Bioanalysis: Vaccine Assay Validation, qPCR Assay Validation, QC for CAR-T Flow Cytometry, NAb Assay Harmonization and ELISpot Validation by Corsaro, Bart, Yang, Tong-yuan, Murphy, Rocio, Sonderegger, Ivo, Exley, Andrew, Bertholet, Sylvie, Dakappagari, Naveen, Dessy, Francis, Garofolo, Fabio, Kierstead, Lisa, Koch, Holger, Sarikonda, Ghanashyam, Savoie, Natasha, Siggers, Richard, Solstad, Therese, Lu, Yanmei, Milton, Mark, Marshall, Jean-Claude, DelCarpini, Jason, Gorovits, Boris, Gupta, Swati, Jesaitis, Lynne, Kamerud, John, Kromminga, Arno, Ma, Anna, McNally, Jim, Yan, Haoheng, Wu, Bonnie, Verthelyi, Daniela, Kirshner, Susan, Pedras-Vasconcelos, Joao, Rajadhyaksha, Manoj, Staack, Roland F., Cherry, Elana, Cludts, Isabelle, Dahlbäck, Madeleine, Gunn, George R., Ishii-Watabe, Akiko, Jawa, Vibha, Kubiak, Robert, Partridge, Michael, Petrillo, Marco, Pine, Samuel O., Poetzl, Johann, Song, Sam, Stebbins, Chris, Wu, Yuling, Zhang, Lucia, Kar, Sumit, Liang, Meina, Abhari, Mohsen Rajabi, Schweighardt, Becky, Stubenrauch, Kay, Xu, Yuanxin

“…The 14 edition of the Workshop on Recent Issues in Bioanalysis (14 WRIB) was held virtually on June 15-29, 2020 with an attendance of over 1000 representatives…”
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Unique challenges required reassessment and alterations to critical reagents to rescue a neutralizing antibody assay by Rowe, Blake A, Medina-Carle, Katie, Chen, Keguan, Reese, Kimberly J, McCarthy, Kenneth M, Concannon, Amy A, Gunn, George R, Gehman, Andrew P, Jiang, Yong, Meyer, Erik

“…To redevelop a neutralizing antibody (NAb) assay to be much more drug tolerant, have a large dynamic range and have high inhibition when using high levels of…”
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Detection of Memory B Activity Against a Therapeutic Protein in Treatment-Naïve Subjects by Liao, Karen, Derbyshire, Stacy, Wang, Kai-fen, Caucci, Cherilyn, Tang, Shuo, Holland, Claire, Loercher, Amy, Gunn, George R.

“…Bridging immunoassays commonly used to detect and characterize immunogenicity during biologic development do not provide direct information on the presence or…”
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Pharmacokinetics and immunogenicity investigation of a human anti-interleukin-17 monoclonal antibody in non-naïve cynomolgus monkeys by Han, Chao, Gunn, George R, Marini, Joseph C, Shankar, Gopi, Han Hsu, Helen, Davis, Hugh M

“…The pharmacokinetics (PK) of biologic therapeutics, especially monoclonal antibodies (mAbs), in monkeys generally presents the most relevant predictive PK…”
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2022 White Paper on Recent Issues in Bioanalysis: FDA Draft Guidance on Immunogenicity Information in Prescription Drug Labeling, LNP & Viral Vectors Therapeutics/Vaccines Immunogenicity, Prolongation Effect, ADA Affinity, Risk-based Approaches, NGS, qPCR, ddPCR Assays by Pan, Luying, Mora, Johanna, Walravens, Karl, Wagner, Leslie, Hopper, Shirley, Loo, Lina, Bettoun, David, Bond, Sarah, Dessy, Francis, Downing, Sean, Garofolo, Fabio, Gupta, Soumi, Henderson, Neil, Irwin, Chad, Ishii-Watabe, Akiko, Kar, Sumit, Jawa, Vibha, Joseph, Julie, Malvaux, Ludovic, Marshall, Jean-Claude, McDevitt, Jessica, Mohapatra, Susovan, Seitzer, Jessica, Smith, Justin, Solstad, Therese, Sugimoto, Hiroshi, Tounekti, Omar, Wu, Bonnie, Wu, Yuling, Xu, Yuanxin, Xu, Joshua, Yamamoto, Takenori, Yang, Lin, Torri, Albert, Kirshner, Susan, Maxfield, Kimberly, Vasconcelos, Joao Pedras, Abhari, Mohsen Rajabi, Verthelyi, Daniela, Brodsky, Eric, Carrasco-Triguero, Montserrat, Kamerud, John, Andisik, Matthew, Baltrukonis, Daniel, Bivi, Nicoletta, Cludts, Isabelle, Coble, Kelly, Gorovits, Boris, Gunn, George R, Gupta, Swati, Millner, Anders Holm, Joyce, Alison, Kubiak, Robert J, Kumar, Seema, Liao, Karen, Manangeeswaran, Mohanraj, Partridge, Michael, Pine, Samuel, Poetzl, Johann, Rajadhyaksha, Manoj, Rasamoelisolo, Michele, Richards, Susan, Song, Yuan, Swanson, Steven, Thacker, Seth, Wadhwa, Meenu, Wolf, Andreas, Zhang, Lucia, Zhou, Lin

“…The 2022 16th Workshop on Recent Issues in Bioanalysis (WRIB) took place in Atlanta, GA, USA on September 26–30, 2022. Over 1000 professionals representing…”
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Two Listeria monocytogenes Vaccine Vectors That Express Different Molecular Forms of Human Papilloma Virus-16 (HPV-16) E7 Induce Qualitatively Different T Cell Immunity That Correlates with Their Ability to Induce Regression of Established Tumors Immortalized by HPV-16 by Gunn, George R, Zubair, Abba, Peters, Christian, Pan, Zhen-Kun, Wu, Tzyy-Choou, Paterson, Yvonne

“…Two recombinant Listeria monocytogenes (rLm) strains were produced that secrete the human papilloma virus-16 (HPV-16) E7 protein expressed in HPV-16-associated…”
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Intradermal vaccination of MUC1 transgenic mice with MUC1/IL-18 plasmid DNA suppresses experimental pulmonary metastases by Shi, Frank F, Gunn, George R, Snyder, Linda A, Goletz, Theresa J

“…Abstract MUC1 (mucin 1) is a transmembrane glycoprotein normally expressed on epithelia of the pancreas, breast, prostate, colon, and lung. However, this…”
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A MUC1/IL-18 DNA vaccine induces anti-tumor immunity and increased survival in MUC1 transgenic mice by Snyder, Linda A., Goletz, Theresa J., Gunn, George R., Shi, Frank F., Harris, Michael C., Cochlin, Karyn, McCauley, Christine, McCarthy, Stephen G., Branigan, Patrick J., Knight, David M.

“…MUC1 (mucin 1) is a tumor-associated antigen that is overexpressed in many adenocarcinomas. Active immunotherapy targeting tumors expressing MUC1 could have…”
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Engineering human IL-18 with increased bioactivity and bioavailability by Swencki-Underwood, Bethany, Cunningham, Mark R., Heavner, George A., Blasie, Cheryl, McCarthy, Stephen G., Dougherty, Tara, Brigham-Burke, Mike, Gunn, George R., Goletz, Theresa J., Snyder, Linda A.

“…Cytokines in plasmid form can act as potent adjuvants when co-administered with DNA vaccines, resulting in an enhanced immune response to the DNA-encoded…”
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Listeriolysin – a useful cytolysin by Gunn, George R, Peters, Christian, Paterson, Yvonne

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