Search Results - "Rup, Bonita"

Immunogenicity of glycans on biotherapeutic drugs produced in plant expression systems-The taliglucerase alfa story by Rup, Bonita, Alon, Sari, Amit-Cohen, Bat-Chen, Brill Almon, Einat, Chertkoff, Raul, Tekoah, Yoram, Rudd, Pauline M

“…Plants are a promising alternative for the production of biotherapeutics. Manufacturing in-planta adds plant specific glycans. To understand immunogenic…”
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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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A bridging assay for detection and characterization of anti-drug antibodies to dostarlimab, a new anti-PD-1 therapeutic monoclonal antibody by Patterson, Marilyn, Beausang, Lee Anne, Rup, Bonita, Bowsher, Ronald R., Krug, Kim, Melhem, Murad, Lu, Sharon

“…Dostarlimab (JEMPERLI) is a humanized anti-programmed death 1 (PD-1) immunoglobulin (Ig)G4-kappa monoclonal antibody that binds to the PD-1 receptor and…”
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Evaluation of Pre-existing Antibody Presence as a Risk Factor for Posttreatment Anti-drug Antibody Induction: Analysis of Human Clinical Study Data for Multiple Biotherapeutics by Xue, Li, Rup, Bonita

“…Biotherapeutic-reactive antibodies in treatment-naïve subjects ( i.e. , pre-existing antibodies) have been commonly detected during clinical immunogenicity…”
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Immunogenicity Risk Assessment for an Engineered Human Cytokine Analogue Expressed in Different Cell Substrates by Chamberlain, Paul, Rup, Bonita

“…The purpose of this article is to illustrate how performance of an immunogenicity risk assessment at the earliest stage of product development can be…”
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Reduced bleeding events with subcutaneous administration of recombinant human factor IX in immune-tolerant hemophilia B dogs by 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.

“…Intravenous administration of recombinant human factor IX (rhFIX) acutely corrects the coagulopathy in hemophilia B dogs. To date, 20 of 20 dogs developed…”
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Therapeutic outcomes, assessments, risk factors and mitigation efforts of immunogenicity of therapeutic protein products by Yin, Liusong, Chen, Xiaoying, Vicini, Paolo, Rup, Bonita, Hickling, Timothy P.

“…•We review therapeutic protein immunogenicity and its impact on efficacy and safety.•Patient- and product-related risk factors for immunogenicity are…”
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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 by 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

“…Pegunigalsidase alfa, a novel PEGylated, covalently crosslinked form of α‐galactosidase A developed as enzyme replacement therapy (ERT) for Fabry disease (FD),…”
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Coupling of Aggregation and Immunogenicity in Biotherapeutics: T- and B-Cell Immune Epitopes May Contain Aggregation-Prone Regions by Kumar, Sandeep, Singh, Satish K., Wang, Xiaoling, Rup, Bonita, Gill, Davinder

“…ABSTRACT Biotherapeutics, including recombinant or plasma-derived human proteins and antibody-based molecules, have emerged as an important class of…”
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Preclinical Models Used for Immunogenicity Prediction of Therapeutic Proteins by Brinks, Vera, Weinbuch, Daniel, Baker, Matthew, Dean, Yann, Stas, Philippe, Kostense, Stefan, Rup, Bonita, Jiskoot, Wim

“…All therapeutic proteins are potentially immunogenic. Antibodies formed against these drugs can decrease efficacy, leading to drastically increased therapeutic…”
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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 by 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

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Two‐center validation of assays for the detection of binding and neutralizing anti‐factor VIII antibodies by Müller, Jens, Neimanis, Sonja, Kahle, Jörg, Albert, Thilo, Schultze Strasser, Stephan, Rup, Bonita, Pötzsch, Bernd, Königs, Christoph, Oldenburg, Johannes

“…Introduction Patients with hemophilia A treated with coagulation Factor VIII (FVIII) products are at risk for developing anti‐FVIII antibodies. The ABIRISK…”
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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 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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Survey Outcome on Immunogenicity Risk Assessment Tools for Biotherapeutics: an Insight into Consensus on Methods, Application, and Utility in Drug Development by 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

“…A survey conducted by the Therapeutic Product Immunogenicity (TPI) community within the American Association of Pharmaceutical Scientists (AAPS) posed…”
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Immunohistochemical detection of bone morphogenetic proteins in bone and soft-tissue sarcomas by Yoshikawa, H, Rettig, W J, Lane, J M, Takaoka, K, Alderman, E, Rup, B, Rosen, V, Healey, J H, Huvos, A G, Garin-Chesa, P

“…Bone morphogenetic proteins (BMPs) are potent inducers of bone formation. Functional and immunohistochemical studies have identified BMPs in a subset of…”
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Critical ligand binding reagent preparation/selection: when specificity depends on reagents by Rup, Bonita, O'Hara, Denise

“…Throughout the life cycle of biopharmaceutical products, bioanalytical support is provided using ligand binding assays to measure the drug product for…”
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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 by Kumar, Sandeep, Mitchell, Mark A, Rup, Bonita, Singh, Satish K

“…Aggregation and unwanted immunogenicity are hurdles to avoid in successful commercial development of antibody-based therapeutics. In this article, the…”
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Recommendations on risk-based strategies for detection and characterization of antibodies against biotechnology products by 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

“…The appropriate evaluation of the immunogenicity of biopharmaceuticals is of major importance for their successful development and licensure. Antibodies…”
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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 by 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

“…The administration of biological therapeutics can evoke some level of immune response to the drug product in the receiving subjects. An immune response…”
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Human recombinant factor IX: safety and efficacy studies in hemophilia B patients previously treated with plasma-derived factor IX concentrates by Roth, David A., Kessler, Craig M., Pasi, K. John, Rup, Bonita, Courter, Suzanne G., Tubridy, Karen L.

“…Human plasma–derived factor IX (pdFIX) concentrates are routinely used to treat patients with hemophilia B, an X-linked bleeding disorder that affects 1 in 30…”
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