Competition-Based Cell Assay Employing Soluble T Cell Receptors to Assess MHC Class II Antigen Processing and Presentation

por Tasker, Carley, Patel, Jenny, Jawa, Vibha, Maamary, Jad
Publicado 2021

Understanding preclinical and clinical immunogenicity risks in novel biotherapeutics development

por Sauna, Zuben E., Jawa, Vibha, Balu-Iyer, Sathy, Chirmule, Narendra
Publicado 2023

Immunogenicity Risk Assessment of Spontaneously Occurring Therapeutic Monoclonal Antibody Aggregates

por Swanson, Michael D., Rios, Shantel, Mittal, Sarita, Soder, George, Jawa, Vibha
Publicado 2022

T-Cell Dependent Immunogenicity of Protein Therapeutics Pre-clinical Assessment and Mitigation–Updated Consensus and Review 2020

por Jawa, Vibha, Terry, Frances, Gokemeijer, Jochem, Mitra-Kaushik, Shibani, Roberts, Brian J., Tourdot, Sophie, De Groot, Anne S.
Publicado 2020

Assessment of romiplostim immunogenicity in adult patients in clinical trials and in a global postmarketing registry

por Mytych, Daniel T., Park, Joseph K., Kim, June, Barger, Troy E., Boshier, Andy, Jawa, Vibha, Kuter, David J.
Publicado 2020

Assessment of immunogenicity of romiplostim in clinical studies with ITP subjects

por Jawa, Vibha, Hokom, Martha, Hu, Zheng, El-Abaadi, Naglaa, Zhuang, Yao, Berger, Dietmar, Gupta, Shalini, Swanson, Steven J., Chirmule, Narendra
Publicado 2010

An Overview of Current Accomplishments and Gaps of COVID-19 Vaccine Platforms and Considerations for Next Generation Vaccines

por Kale, Akanksha, Gaur, Amitabh, Menon, Ipshita, Chirmule, Narendra, Bagwe, Priyal, Jawa, Rayan, Vijayanand, Sharon, Patil, Smital, Suresh, Surekha, Jawa, Vibha
Publicado 2023

Highly Aggregated Antibody Therapeutics Can Enhance the in Vitro Innate and Late-stage T-cell Immune Responses

por Joubert, Marisa K., Hokom, Martha, Eakin, Catherine, Zhou, Lei, Deshpande, Meghana, Baker, Matthew P., Goletz, Theresa J., Kerwin, Bruce A., Chirmule, Naren, Narhi, Linda O., Jawa, Vibha
Publicado 2012

Identification and characterization of a residual host cell protein hexosaminidase B associated with N‐glycan degradation during the stability study of a therapeutic recombinant mo...

por Li, Xuanwen, An, Yan, Liao, Jing, Xiao, Li, Swanson, Michael, Martinez‐Fonts, Kirby, Pavon, Jorge Alexander, Sherer, Edward C., Jawa, Vibha, Wang, Fengqiang, Gao, Xinliu, Letarte, Simon, Richardson, Douglas D.
Publicado 2021

Evaluation of the Humoral Response to Adeno-Associated Virus-Based Gene Therapy Modalities Using Total Antibody Assays

por Gorovits, Boris, Azadeh, Mitra, Buchlis, George, Harrison, Travis, Havert, Mike, Jawa, Vibha, Long, Brian, McNally, Jim, Milton, Mark, Nelson, Robert, O’Dell, Mark, Richards, Karen, Vettermann, Christian, Wu, Bonnie
Publicado 2021

Assay format diversity in pre-clinical immunogenicity risk assessment: Toward a possible harmonization of antigenicity assays

por Ducret, Axel, Ackaert, Chloé, Bessa, Juliana, Bunce, Campbell, Hickling, Timothy, Jawa, Vibha, Kroenke, Mark A., Lamberth, Kasper, Manin, Anaïs, Penny, Hweixian L., Smith, Noel, Terszowski, Grzegorz, Tourdot, Sophie, Spindeldreher, Sebastian
Publicado 2021

Evaluation of Cellular Immune Response to Adeno-Associated Virus-Based Gene Therapy

por Gorovits, Boris, Azadeh, Mitra, Buchlis, George, Fiscella, Michele, Harrison, Travis, Havert, Mike, Janetzki, Sylvia, Jawa, Vibha, Long, Brian, Mahnke, Yolanda D., McDermott, Andrew, Milton, Mark, Nelson, Robert, Vettermann, Christian, Wu, Bonnie
Publicado 2023

Use of In Vitro Assays to Assess Immunogenicity Risk of Antibody-Based Biotherapeutics

por Joubert, Marisa K., Deshpande, Meghana, Yang, Jane, Reynolds, Helen, Bryson, Christine, Fogg, Mark, Baker, Matthew P., Herskovitz, Jonathan, Goletz, Theresa J., Zhou, Lei, Moxness, Michael, Flynn, Gregory C., Narhi, Linda O., Jawa, Vibha
Publicado 2016

Immunogenicity assessment of AAV-based gene therapies: An IQ consortium industry white paper

por Yang, Tong-yuan, Braun, Manuela, Lembke, Wibke, McBlane, Fraser, Kamerud, John, DeWall, Stephen, Tarcsa, Edit, Fang, Xiaodong, Hofer, Lena, Kavita, Uma, Upreti, Vijay V., Gupta, Swati, Loo, LiNa, Johnson, Alison J., Chandode, Rakesh Kantilal, Stubenrauch, Kay-Gunnar, Vinzing, Maya, Xia, Cindy Q., Jawa, Vibha
Publicado 2022

Anti-drug Antibody Validation Testing and Reporting Harmonization

por 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
Publicado 2021