Immunogenicity of biologically-derived therapeutics: Assessment and interpretation of nonclinical safety studies
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
Published in Regulatory toxicology and pharmacology (01.07.2009)
Published in Regulatory toxicology and pharmacology (01.07.2009)
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A bridging assay for detection and characterization of anti-drug antibodies to dostarlimab, a new anti-PD-1 therapeutic monoclonal antibody
Patterson, Marilyn, Beausang, Lee Anne, Rup, Bonita, Bowsher, Ronald R., Krug, Kim, Melhem, Murad, Lu, Sharon
Published in AAPS open (20.12.2021)
Published in AAPS open (20.12.2021)
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Reduced bleeding events with subcutaneous administration of recombinant human factor IX in immune-tolerant hemophilia B dogs
Russell, Karen E., Olsen, Eva H.N., Raymer, Robin A., Merricks, Elizabeth P., Bellinger, Dwight A., Read, Marjorie S., Rup, Bonita J., Keith, James C., McCarthy, Kyle P., Schaub, Robert G., Nichols, Timothy C.
Published in Blood (15.12.2003)
Published in Blood (15.12.2003)
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Pegunigalsidase alfa, a novel PEGylated enzyme replacement therapy for Fabry disease, provides sustained plasma concentrations and favorable pharmacodynamics: A 1‐year Phase 1/2 clinical trial
Schiffmann, Raphael, Goker‐Alpan, Ozlem, Holida, Myrl, Giraldo, Pilar, Barisoni, Laura, Colvin, Robert B., Jennette, Charles J., Maegawa, Gustavo, Boyadjiev, Simeon A., Gonzalez, Derlis, Nicholls, Kathy, Tuffaha, Ahmad, Atta, Mohamed G., Rup, Bonita, Charney, Martha R., Paz, Alona, Szlaifer, Mali, Alon, Sari, Brill‐Almon, Einat, Chertkoff, Raul, Hughes, Derralynn
Published in Journal of inherited metabolic disease (01.05.2019)
Published in Journal of inherited metabolic disease (01.05.2019)
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Preclinical Models Used for Immunogenicity Prediction of Therapeutic Proteins
Brinks, Vera, Weinbuch, Daniel, Baker, Matthew, Dean, Yann, Stas, Philippe, Kostense, Stefan, Rup, Bonita, Jiskoot, Wim
Published in Pharmaceutical research (01.07.2013)
Published in Pharmaceutical research (01.07.2013)
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Assessment of immunogenicity from the pegunigalsidase alfa clinical trial program: Integrated analysis of de novo and treatment-boosted anti-drug antibodies
Bernat, John, Hughes, Derralynn, Linhart, Aleš, Hopkin, Robert J., Tøndel, Camilla, Warnock, David G., Rup, Bonita, Koulinska, Irene, Rocco, Rossana, Alon, Sari, Chertkoff, Raul, Almon, Einat Brill, Sakov, Anat, Wallace, Eric
Published in Molecular genetics and metabolism (01.02.2024)
Published in Molecular genetics and metabolism (01.02.2024)
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Two‐center validation of assays for the detection of binding and neutralizing anti‐factor VIII antibodies
Müller, Jens, Neimanis, Sonja, Kahle, Jörg, Albert, Thilo, Schultze Strasser, Stephan, Rup, Bonita, Pötzsch, Bernd, Königs, Christoph, Oldenburg, Johannes
Published in Haemophilia : the official journal of the World Federation of Hemophilia (01.01.2024)
Published in Haemophilia : the official journal of the World Federation of Hemophilia (01.01.2024)
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Recommendations for the validation of cell-based assays used for the detection of neutralizing antibody immune responses elicited against biological therapeutics
Gupta, Shalini, Devanarayan, Viswanath, Finco, Deborah, Gunn, George R., Kirshner, Susan, Richards, Susan, Rup, Bonita, Song, An, Subramanyam, Meena
Published in Journal of pharmaceutical and biomedical analysis (15.07.2011)
Published in Journal of pharmaceutical and biomedical analysis (15.07.2011)
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Survey Outcome on Immunogenicity Risk Assessment Tools for Biotherapeutics: an Insight into Consensus on Methods, Application, and Utility in Drug Development
Gokemeijer, Jochem, Wen, Yi, Jawa, Vibha, Mitra-Kaushik, Shibani, Chung, Shan, Goggins, Alan, Kumar, Seema, Lamberth, Kasper, Liao, Karen, Lill, Jennie, Phung, Qui, Walsh, Robin, Roberts, Brian J., Swanson, Michael, Singh, Inderpal, Tourdot, Sophie, Kroenke, Mark A., Rup, Bonita, Goletz, Theresa J., Gupta, Swati, Malherbe, Laurent, Pattijn, Sofie
Published in The AAPS journal (02.06.2023)
Published in The AAPS journal (02.06.2023)
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Immunohistochemical detection of bone morphogenetic proteins in bone and soft‐tissue sarcomas
Yoshikawa, Hideki, Rettig, Wolfgang J., Lane, Joseph M., Takaoka, Kunio, Alderman, Edward, Rup, Bonita, Rosen, Vicki, Healey, John H., Huvos, Andrew G., Garin‐Chesa, Pilar
Published in Cancer (01.08.1994)
Published in Cancer (01.08.1994)
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Relationship Between Potential Aggregation-Prone Regions and HLA-DR-Binding T-Cell Immune Epitopes: Implications for Rational Design of Novel and Follow-on Therapeutic Antibodies
Kumar, Sandeep, Mitchell, Mark A., Rup, Bonita, Singh, Satish K.
Published in Journal of pharmaceutical sciences (01.08.2012)
Published in Journal of pharmaceutical sciences (01.08.2012)
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Recommendations on risk-based strategies for detection and characterization of antibodies against biotechnology products
Koren, Eugen, Smith, Holly W., Shores, Elizabeth, Shankar, Gopi, Finco-Kent, Deborah, Rup, Bonita, Barrett, Yu-Chen, Devanarayan, Viswanath, Gorovits, Boris, Gupta, Shalini, Parish, Thomas, Quarmby, Valerie, Moxness, Michael, Swanson, Steven J., Taniguchi, Gary, Zuckerman, Linda A., Stebbins, Christopher C., Mire-Sluis, Anthony
Published in Journal of immunological methods (20.04.2008)
Published in Journal of immunological methods (20.04.2008)
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Recommendations for the design, optimization, and qualification of cell-based assays used for the detection of neutralizing antibody responses elicited to biological therapeutics
Gupta, Shalini, Indelicato, Stephen R., Jethwa, Vijay, Kawabata, Thomas, Kelley, Marian, Mire-Sluis, Anthony R., Richards, Susan M., Rup, Bonita, Shores, Elizabeth, Swanson, Steven J., Wakshull, Eric
Published in Journal of immunological methods (10.04.2007)
Published in Journal of immunological methods (10.04.2007)
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