| Immunogenicity to therapeutic proteins: impact on PK/PD and efficacy N Chirmule, V Jawa, B Meibohm The AAPS journal 14, 296-302, 2012 | 332 | 2012 |
| Highly aggregated antibody therapeutics can enhance the in vitro innate and late-stage T-cell immune responses MK Joubert, M Hokom, C Eakin, L Zhou, M Deshpande, MP Baker, ... Journal of Biological Chemistry 287 (30), 25266-25279, 2012 | 295 | 2012 |
| T-cell dependent immunogenicity of protein therapeutics: preclinical assessment and mitigation V Jawa, LP Cousens, M Awwad, E Wakshull, H Kropshofer, AS De Groot Clinical immunology 149 (3), 534-555, 2013 | 269 | 2013 |
| Clinical validation of the “in silico” prediction of immunogenicity of a human recombinant therapeutic protein E Koren, AS De Groot, V Jawa, KD Beck, T Boone, D Rivera, L Li, ... Clinical Immunology 124 (1), 26-32, 2007 | 171 | 2007 |
| Use of In Vitro Assays to Assess Immunogenicity Risk of Antibody-Based Biotherapeutics MK Joubert, M Deshpande, J Yang, H Reynolds, C Bryson, M Fogg, ... PloS one 11 (8), e0159328, 2016 | 109 | 2016 |
| Mouse models for assessing protein immunogenicity: lessons and challenges W Jiskoot, G Kijanka, TW Randolph, JF Carpenter, AV Koulov, HC Mahler, ... Journal of pharmaceutical sciences 105 (5), 1567-1575, 2016 | 104 | 2016 |
| T-cell dependent immunogenicity of protein therapeutics pre-clinical assessment and mitigation–updated consensus and review 2020 V Jawa, F Terry, J Gokemeijer, S Mitra-Kaushik, BJ Roberts, S Tourdot, ... Frontiers in immunology 11, 1301, 2020 | 88 | 2020 |
| Immunogenicity testing by electrochemiluminescent detection for antibodies directed against therapeutic human monoclonal antibodies M Moxness, S Tatarewicz, D Weeraratne, N Murakami, D Wullner, ... Clinical chemistry 51 (10), 1983-1985, 2005 | 84 | 2005 |
| Considerations for optimization and validation of an in vitro PBMC derived T cell assay for immunogenicity prediction of biotherapeutics D Wullner, L Zhou, E Bramhall, A Kuck, TJ Goletz, S Swanson, ... Clinical immunology 137 (1), 5-14, 2010 | 83 | 2010 |
| 2019 white paper on recent issues in bioanalysis: FDA immunogenicity guidance, gene therapy, critical reagents, biomarkers and flow cytometry validation (part 3–recommendations … S Piccoli, D Mehta, A Vitaliti, J Allinson, S Amur, S Eck, C Green, ... Bioanalysis 11 (24), 2207-2244, 2019 | 81 | 2019 |
| Evaluating immunogenicity risk due to host cell protein impurities in antibody-based biotherapeutics V Jawa, MK Joubert, Q Zhang, M Deshpande, S Hapuarachchi, MP Hall, ... The AAPS journal 18, 1439-1452, 2016 | 77 | 2016 |
| Perspectives on subcutaneous route of administration as an immunogenicity risk factor for therapeutic proteins L Hamuro, G Kijanka, F Kinderman, H Kropshofer, D Bu, M Zepeda, ... Journal of Pharmaceutical Sciences 106 (10), 2946-2954, 2017 | 74 | 2017 |
| Physical characterization and in vitro biological impact of highly aggregated antibodies separated into size-enriched populations by fluorescence-activated cell sorting S Telikepalli, HE Shinogle, PS Thapa, JH Kim, M Deshpande, V Jawa, ... Journal of pharmaceutical sciences 104 (5), 1575-1591, 2015 | 60 | 2015 |
| Development of a human antibody tolerant mouse model to assess the immunogenicity risk due to aggregated biotherapeutics V Bi, V Jawa, MK Joubert, A Kaliyaperumal, C Eakin, K Richmond, O Pan, ... Journal of pharmaceutical sciences 102 (10), 3545-3555, 2013 | 56 | 2013 |
| 2018 White Paper on Recent Issues in Bioanalysis: focus on flow cytometry, gene therapy, cut points and key clarifications on BAV (Part 3–LBA/cell-based assays: immunogenicity … L Stevenson, S Richards, R Pillutla, A Torri, J Kamerud, D Mehta, S Keller, ... Bioanalysis 10 (24), 1973-2001, 2018 | 49 | 2018 |
| 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 … B Corsaro, T Yang, R Murphy, I Sonderegger, A Exley, S Bertholet, ... Bioanalysis 13 (6), 415-463, 2021 | 42 | 2021 |
| Impact of anti-drug antibodies in preclinical pharmacokinetic assessment TM Thway, I Magana, A Bautista, V Jawa, W Gu, M Ma The AAPS journal 15, 856-863, 2013 | 42 | 2013 |
| How Close Are We to Profiling Immunogenicity Risk Using In Silico Algorithms and In Vitro Methods?: an Industry Perspective J Gokemeijer, V Jawa, S Mitra-Kaushik The AAPS Journal 19, 1587-1592, 2017 | 41 | 2017 |
| Evaluation of the humoral response to adeno-associated virus-based gene therapy modalities using total antibody assays B Gorovits, M Azadeh, G Buchlis, T Harrison, M Havert, V Jawa, B Long, ... The AAPS journal 23, 1-17, 2021 | 40 | 2021 |
| Immunogenicity assessment of AAV-based gene therapies: an IQ consortium industry white paper T Yang, M Braun, W Lembke, F McBlane, J Kamerud, S DeWall, E Tarcsa, ... Molecular Therapy-Methods & Clinical Development 26, 471-494, 2022 | 31 | 2022 |
