The Impact of Pre-existing Immunity on the Non-clinical Pharmacodynamics of AAV5-Based Gene Therapy by Long, Brian R., Sandza, Krystal, Holcomb, Jennifer, Crockett, Lucy, Hayes, Gregory M., Arens, Jeremy, Fonck, Carlos, Tsuruda, Laurie S., Schweighardt, Becky, O’Neill, Charles A., Zoog, Stephen, Vettermann, Christian

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Long-Term Immunogenicity of Elosulfase Alfa in the Treatment of Morquio A Syndrome: Results From MOR-005, a Phase III Extension Study by Long, Brian, PhD, Tompkins, Troy, BS, Decker, Celeste, MD, Jesaitis, Lynne, PhD, Khan, Shahid, MBBS, Slasor, Peter, ScD, Harmatz, Paul, MD, O’Neill, Charles A., PhD, Schweighardt, Becky, PhD

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AAV9-NGLY1 gene replacement therapy improves phenotypic and biomarker endpoints in a rat model of NGLY1 Deficiency by Zhu, Lei, Tan, Brandon, Dwight, Selina S., Beahm, Brendan, Wilsey, Matt, Crawford, Brett E., Schweighardt, Becky, Cook, Jennifer W., Wechsler, Thomas, Mueller, William F.

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Immunogenicity of Elosulfase Alfa, an Enzyme Replacement Therapy in Patients With Morquio A Syndrome: Results From MOR-004, a Phase III Trial by Schweighardt, Becky, PhD, Tompkins, Troy, BS, Lau, Kelly, MS, Jesaitis, Lynne, PhD, Qi, Yulan, PhD, Musson, Donald G., PhD, Farmer, Pamela, MD, Haller, Christine, MD, Shaywitz, Adam J., MD, PhD, Yang, Ke, PhD, O’Neill, Charles A., PhD

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Pharmacokinetic, pharmacodynamic, and immunogenic rationale for optimal dosing of pegvaliase, a PEGylated bacterial enzyme, in adult patients with phenylketonuria by Qi, Yulan, Patel, Gina, Henshaw, Joshua, Gupta, Soumi, Olbertz, Joy, Larimore, Kevin, Harding, Cary O., Merilainen, Markus, Zori, Roberto, Longo, Nicola, Burton, Barbara K., Li, Mingjin, Gu, Zhonghua, Zoog, Stephen J., Weng, Haoling H., Schweighardt, Becky

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High Specific Infectivity of Plasma Virus from the Pre-Ramp-Up and Ramp-Up Stages of Acute Simian Immunodeficiency Virus Infection by MA, Zhong-Min, STONE, Mars, PIATAK, Mike, SCHWEIGHARDT, Becky, HAIGWOOD, Nancy L, MONTEFIORI, David, LIFSON, Jeffrey D, BUSCH, Michael P, MILLER, Christopher J

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Rapid Escape from Preserved Cross-Reactive Neutralizing Humoral Immunity without Loss of Viral Fitness in HIV-1-Infected Progressors and Long-Term Nonprogressors by VAN GILS, Marit J, BUNNIK, Evelien M, BURGER, Judith A, JACOB, Yodit, SCHWEIGHARDT, Becky, WRIN, Terri, SCHUITEMAKER, Hanneke

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Neutralizing Antibody Responses against Autologous and Heterologous Viruses in Acute versus Chronic Human Immunodeficiency Virus (HIV) Infection: Evidence for a Constraint on the A... by DEEKS, Steven G, SCHWEIGHARDT, Becky, HECHT, Frederick M, WRIN, Terri, GALOVICH, Justin, HOH, Rebecca, SINCLAIR, Elizabeth, HUNT, Peter, MCCUNE, Joseph M, MARTIN, Jeffrey N, PETROPOULOS, Christos J

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Mutation at a Single Position in the V2 Domain of the HIV-1 Envelope Protein Confers Neutralization Sensitivity to a Highly Neutralization-Resistant Virus by O'ROURKE, Sara M, SCHWEIGHARDT, Becky, PHUNG, Pham, FONSECA, Dora P. A. J, TERRY, Karianne, WRIN, Terri, SINANGIL, Faruk, BERMAN, Phillip W

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Sequences in Glycoprotein gp41, the CD4 Binding Site, and the V2 Domain Regulate Sensitivity and Resistance of HIV-1 to Broadly Neutralizing Antibodies by O'ROURKE, Sara M, SCHWEIGHARDT, Becky, BERMAN, Phillip W, PHUNG, Pham, MESA, Kathryn A, VOLLRATH, Aaron L, TATSUNO, Gwen P, TO, Briana, SINANGIL, Faruk, LIMOLI, Kay, WRIN, Terri

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Novel Ring Structure in the gp41 Trimer of Human Immunodeficiency Virus Type 1 That Modulates Sensitivity and Resistance to Broadly Neutralizing Antibodies by O'ROURKE, Sara M, SCHWEIGHARDT, Becky, SCOTT, William G, WRIN, Terri, FONSECA, Dora P. A. J, SINANGIL, Faruk, BERMAN, Phillip W

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Early Phase Clinical Immunogenicity of Valoctocogene Roxaparvovec, an AAV5-Mediated Gene Therapy for Hemophilia A by Long, Brian R., Veron, Philippe, Kuranda, Klaudia, Hardet, Romain, Mitchell, Nina, Hayes, Gregory M., Wong, Wing Yen, Lau, Kelly, Li, Mingjin, Hock, M. Benjamin, Zoog, Stephen J., Vettermann, Christian, Mingozzi, Federico, Schweighardt, Becky

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Immunogenicity to cerliponase alfa intracerebroventricular enzyme replacement therapy for CLN2 disease: Results from a Phase 1/2 study by Cherukuri, Anu, Cahan, Heather, de Hart, Greg, Van Tuyl, Andrea, Slasor, Peter, Bray, Laurie, Henshaw, Joshua, Ajayi, Temitayo, Jacoby, Dave, O'Neill, Charles A., Schweighardt, Becky

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PEGylated Biopharmaceuticals: Current Experience and Considerations for Nonclinical Development by Ivens, Inge A., Achanzar, William, Baumann, Andreas, Brändli-Baiocco, Annamaria, Cavagnaro, Joy, Dempster, Maggie, Depelchin, B. Olympe, Irizarry Rovira, Armando R., Dill-Morton, Laura, Lane, Joan H., Reipert, Birgit M., Salcedo, Theodora, Schweighardt, Becky, Tsuruda, Laurie S., Turecek, Peter L., Sims, Jennifer

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R5 Human Immunodeficiency Virus Type 1 (HIV-1) Replicates More Efficiently in Primary CD4+ T-Cell Cultures Than X4 HIV-1 by SCHWEIGHARDT, Becky, ROY, Ann-Marie, MEIKLEJOHN, Duncan A, GRACE, Edward J, MORETTO, Walter J, HEYMANN, Jonas J, NIXON, Douglas F

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Induction, titration, and maintenance dosing regimen in a phase 2 study of pegvaliase for control of blood phenylalanine in adults with phenylketonuria by Zori, Roberto, Thomas, Janet A., Shur, Natasha, Rizzo, William B., Decker, Celeste, Rosen, Orli, Li, Mingjin, Schweighardt, Becky, Larimore, Kevin, Longo, Nicola

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Cross-Reactive Neutralizing Humoral Immunity Does Not Protect from HIV Type 1 Disease Progression by Euler, Zelda, van Gils, Marit J., Bunnik, Evelien M., Phung, Pham, Schweighardt, Becky, Wrin, Terri, Schuitemaker, Hanneke

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2019 White Paper on Recent Issues in Bioanalysis: FDA Immunogenicity Guidance, Gene Therapy, Critical Reagents, Biomarkers and Flow Cytometry Validation (Part 3 – Recommendations o... by Piccoli, Steven, Mehta, Devangi, Vitaliti, Alessandra, Allinson, John, Amur, Shashi, Eck, Steve, Green, Cherie, Hedrick, Michael, Hopper, Shirley, Ji, Allena, Joyce, Alison, Litwin, Virginia, Maher, Kevin, Mathews, Joel, Peng, Kun, Safavi, Afshin, Wang, Yow-Ming, Zhang, Yan, Amaravadi, Lakshmi, Palackal, Nisha, Thankamony, Sai, Beaver, Chris, Bame, Eris, Emrich, Thomas, Grimaldi, Christine, Haulenbeek, Jonathan, Kakkanaiah, Vellalore, Lanham, David, Mayer, Andrew, Trampont, Paul C, Vermet, Laurent, Dakappagari, Naveen, Fleener, Catherine, Garofolo, Fabio, Rogers, Cynthia, Tangri, Shabnam, Xu, Yuanxin, Liang, Meina, Rajadhyaksha, Manoj, Richards, Susan, Schweighardt, Becky, Purushothama, Shobha, Baltrukonis, Daniel, Brumm, Jochen, Cherry, Elana, Delcarpini, Jason, Gleason, Carol, Kirshner, Susan, Kubiak, Robert, Pan, Luying, Partridge, Michael, Pedras-Vasconcelos, João, Qu, Qiang, Skibeli, Venke, Saunders, Therese Solstad, Staack, Roland F, Stubenrauch, Kay, Torri, Al, Verthelyi, Daniela, Yan, Haoheng, Gorovits, Boris, Palmer, Rachel, Milton, Mark, Long, Brian, Corsaro, Bart, Farrokhi, Vahid, Fiscella, Michele, Henderson, Neil, Jawa, Vibha, McNally, Jim, Murphy, Rocio, Waldner, Hanspeter, Yang, Tong-Yuan

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Association of immune response with efficacy and safety outcomes in adults with phenylketonuria administered pegvaliase in phase 3 clinical trials by Gupta, Soumi, Lau, Kelly, Harding, Cary O., Shepherd, Gillian, Boyer, Ryan, Atkinson, John P., Knight, Vijaya, Olbertz, Joy, Larimore, Kevin, Gu, Zhonghu, Li, Mingjin, Rosen, Orli, Zoog, Stephen J., Weng, Haoling H., Schweighardt, Becky

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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

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