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Development of a Novel BAFF Responsive Cell Line Suitable for Detecting Bioactive BAFF and Neutralizing Antibodies against BAFF-Pathway Inhibiting Therapeutics
Hu, Jenny, Yu, Yanbin, Han, Hong, Civoli, Francesca, Zhuang, Yao, Thomas, John, Swanson, Steve, Jing, Shuqian, Gupta, Shalini
Published in Cells (Basel, Switzerland) (10.02.2014)
Published in Cells (Basel, Switzerland) (10.02.2014)
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Pharmacokinetic and Pharmacodynamic Bioequivalence of Pegfilgrastim-cbqv Delivered via a Prefilled Autoinjector and Prefilled Syringe in Healthy Male Participants
Tang, Hong, Civoli, Francesca, Tatarewicz, Suzanna, Vandenkoornhuyse, Nathalie, Finck, Barbara
Published in Advances in therapy (01.11.2023)
Published in Advances in therapy (01.11.2023)
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A Randomized, Open-Label Study Conducted to Evaluate the Bioequivalence of Pegfilgrastim-cbqv On-Body Injector Versus Prefilled Syringe in Healthy Male Participants
Tang, Hong, Civoli, Francesca, Tatarewicz, Suzanna, Vandenkoornhuyse, Nathalie, Finck, Barbara
Published in Advances in therapy (01.03.2024)
Published in Advances in therapy (01.03.2024)
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A randomized, open-label, crossover study assessing the pharmacokinetic and pharmacodynamic bioequivalence of pegfilgrastim-cbqv via on-body injector vs prefilled syringe
Tang, Hong, Civoli, Francesca, Tatarewicz, Suzanna, Miyasaki, Lisa, O'Kelly, Hillary, Young, Alasdair, Finck, Barbara
Published in Journal of clinical oncology (01.06.2022)
Published in Journal of clinical oncology (01.06.2022)
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Biosimilar Pegfilgrastim-cbqv Demonstrated Similar Immunogenicity to Pegfilgrastim in Healthy Subjects Across Three Randomized Clinical Studies
Civoli, Francesca, Finck, Barbara, Tang, Helen, Hodge, Jennifer, O’Kelly, Hillary, Vexler, Vladimir
Published in Advances in therapy (01.03.2022)
Published in Advances in therapy (01.03.2022)
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Recommendations for the Development and Validation of Immunogenicity Assays in Support of Biosimilar Programs
Civoli, Francesca, Kasinath, Aparna, Cai, Xiao-Yan, Wadhwa, Meenu, Exley, Andrew, Oldfield, Philip, Alvandkouhi, Safa, Schaffar, Gregor, Chappell, John, Bowsher, Ronald, Devanarayan, Viswanath, Marini, Joseph, Rebarchak, Shannon, Anderson, Michael, Koppenburg, Vera, Lester, Todd
Published in The AAPS journal (01.01.2020)
Published in The AAPS journal (01.01.2020)
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Neutralizing Antibody Validation Testing and Reporting Harmonization
Myler, Heather, Pedras-Vasconcelos, João, Lester, Todd, Civoli, Francesca, Xu, Weifeng, Wu, Bonnie, Vainshtein, Inna, Luo, Linlin, Hassanein, Mohamed, Liu, Susana, Ramaswamy, Swarna Suba, Mora, Johanna, Pennucci, Jason, McCush, Fred, Lavelle, Amy, Jani, Darshana, Ambakhutwala, Angela, Baltrukonis, Daniel, Barker, Breann, Carmean, Rebecca, Chung, Shan, Dai, Sheng, DeWall, Stephen, Dholakiya, Sanjay L., Dodge, Robert, Finco, Deborah, Yan, Haoheng, Hays, Amanda, Hu, Zheng, Inzano, Cynthia, Kamen, Lynn, Lai, Ching-Ha, Meyer, Erik, Nelson, Robert, Paudel, Amrit, Phillips, Kelli, Poupart, Marie-Eve, Qu, Qiang, Abhari, Mohsen Rajabi, Ryding, Janka, Sheldon, Curtis, Spriggs, Franklin, Warrino, Dominic, Wu, Yuling, Yang, Lin, Pasas-Farmer, Stephanie
Published in The AAPS journal (08.07.2023)
Published in The AAPS journal (08.07.2023)
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Comparison of cell-based and non-cell-based assay platforms for the detection of clinically relevant anti-drug neutralizing antibodies for immunogenicity assessment of therapeutic proteins
Hu, Jenny, Wala, Iwona, Han, Hong, Nagatani, Janice, Barger, Troy, Civoli, Francesca, Kaliyaperumal, Arunan, Zhuang, Yao, Gupta, Shalini
Published in Journal of immunological methods (01.04.2015)
Published in Journal of immunological methods (01.04.2015)
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Implementation of design of experiments (DOE) in the development and validation of a cell-based bioassay for the detection of anti-drug neutralizing antibodies in human serum
Chen, Xinyi C., Zhou, Lei, Gupta, Shalini, Civoli, Francesca
Published in Journal of immunological methods (28.02.2012)
Published in Journal of immunological methods (28.02.2012)
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Development and characterization of a human antibody reference panel against erythropoietin suitable for the standardization of ESA immunogenicity testing
Mytych, Daniel T., Barger, Troy E., King, Chadwick, Grauer, Stephanie, Haldankar, Raj, Hsu, Eric, Wu, Michelle Min, Shiwalkar, Mukta, Sanchez, Sergio, Kuck, Andrew, Civoli, Francesca, Sun, Jilin, Swanson, Steven J.
Published in Journal of immunological methods (31.08.2012)
Published in Journal of immunological methods (31.08.2012)
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Development and optimization of neutralizing antibody assays to monitor clinical immunogenicity
Civoli, Francesca, Kroenke, Mark A, Reynhardt, Kaz, Zhuang, Yao, Kaliyaperumal, Arunan, Gupta, Shalini
Published in Bioanalysis (01.11.2012)
Published in Bioanalysis (01.11.2012)
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Strategy to confirm the presence of anti-erythropoietin neutralizing antibodies in human serum
Sanchez, Sergio, Barger, Troy, Zhou, Lei, Hale, Michael, Mytych, Daniel, Gupta, Shalini, Swanson, Steven J., Civoli, Francesca
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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Ligand Binding Assays in the 21st Century Laboratory: Automation
Ahene, Ago B., Morrow, Chris, Rusnak, David, Spitz, Susan, Usansky, Joel, Pils, Holger, Civoli, Francesca, Pandya, Kinnari, Sue, Brian, Leach, Daniel, Derent, John
Published in The AAPS journal (01.03.2012)
Published in The AAPS journal (01.03.2012)
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S.4. Predictive Value of Antibody Concentrations on the Generation of Neutralizing Antibodies to Therapeutic Proteins
Bautista, Ami, Han, Hong, Civoli, Francesca, Gupta, Shalini, Swanson, Steven, Chirmule, Narendra, Jawa, Vibha
Published in Clinical immunology (Orlando, Fla.) (2009)
Published in Clinical immunology (Orlando, Fla.) (2009)
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