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Suggested authors matching "AUTH:Jawa V" with an ORCID

Vibha Jawa
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Determining the Degree of Sulfo-tag Conjugation to AAV5 Vectors by LC-HRMS and Evaluating the Effects on Antibody Binding Affinity and Bridging Assay Sensitivity.
Dai Y, Wu X, Sun X, Cohen D, Rajeswaran D, Robotham S, Chilewski S, Yang K, Yearwood G, Kozhich A, Jawa V
AAPS J, 26(6):104, 16 Sep 2024
Cited by: 0 articles | PMID: 39285067
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Industry Perspective on First-in-Human and Clinical Pharmacology Strategies to Support Clinical Development of T-Cell Engaging Bispecific Antibodies for Cancer Therapy.
Nagaraja Shastri P, Shah N, Lechmann M, Mody H, Retter MW, Zhu M, Li T, Wang J, Shaik N, Zheng X, Ovacik M, Hua F, Jawa V, Boetsch C, Cao Y, Burke J, Datta K, Gadkar K, Upreti V, Betts A
Clin Pharmacol Ther, 19 Sep 2024
Cited by: 0 articles | PMID: 39295563
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Applications of Organoids in Advancing Drug Discovery and Development.
Gopallawa I, Gupta C, Jawa R, Cyril A, Jawa V, Chirmule N, Gujar V
J Pharm Sci, 113(9):2659-2667, 20 Jul 2024
Cited by: 0 articles | PMID: 39002723
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Immunogenicity Risk Assessment of Process-Related Impurities in An Engineered T Cell Receptor Cellular Product.
Mora J, Forman D, Hu J, Ijantkar A, Gokemeijer J, Kolaja KL, Picarillo C, Jawa V, Yue H, Lamy J, Denies S, Schockaert J, Ackaert C
J Pharm Sci, 113(8):2151-2160, 18 May 2024
Cited by: 0 articles | PMID: 38768755
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A High Threshold of Biotherapeutic Aggregate Numbers is Needed to Induce an Immunogenic Response In Vitro, In Vivo, and in the Clinic.
Cohen JR, Brych SR, Prabhu S, Bi V, Elbaradei A, Tokuda JM, Xiang C, Hokom M, Cui X, Ly C, Amos N, Sun J, Calamba D, Herskovitz J, Capili A, Nourbakhsh K, Merlo A, Carreon J, Wypych J, [...] Joubert MK
Pharm Res, 41(4):651-672, 22 Mar 2024
Cited by: 0 articles | PMID: 38519817
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Preexisting antibody assays for gene therapy: Considerations on patient selection cutoffs and companion diagnostic requirements.
Braun M, Lange C, Schatz P, Long B, Stanta J, Gorovits B, Tarcsa E, Jawa V, Yang TY, Lembke W, Miller N, McBlane F, Christodoulou L, Yuill D, Milton M
Mol Ther Methods Clin Dev, 32(1):101217, 20 Feb 2024
Cited by: 2 articles | PMID: 38496304 | PMCID: PMC10944107
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This article is in the Europe PMC Open access subset. Refer to the copyright information in the article for licensing details.
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An IQ Consortium Perspective on Best Practices for Bioanalytical and Immunogenicity Assessment Aspects of CAR-T and TCR-T Cellular Therapies Development.
Gokemeijer J, Balasubramanian N, Ogasawara K, Grudzinska-Goebel J, Upreti VV, Mody H, Kasar S, Vepachedu VR, Xu W, Gupta S, Tarcsa E, Dodge R, Herr K, Yang TY, Tourdot S, Jawa V
Clin Pharmacol Ther, 115(2):188-200, 17 Dec 2023
Cited by: 0 articles | PMID: 37983584
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Best Practices and Considerations for Clinical Pharmacology and Pharmacometric Aspects for Optimal Development of CAR-T and TCR-T Cell Therapies: An Industry Perspective.
Mody H, Ogasawara K, Zhu X, Miles D, Shastri PN, Gokemeijer J, Liao MZ, Kasichayanula S, Yang TY, Chemuturi N, Gupta S, Jawa V, Upreti VV
Clin Pharmacol Ther, 114(3):530-557, 26 Jul 2023
Cited by: 3 articles | PMID: 37393588
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Bioanalytical Methods for Characterization of CAR-T Cellular Kinetics: Comparison of PCR Assays and Matrices.
Masilamani M, Jawa V, Dai Y, Das R, Park A, Lamba M, Wu F, Zheng X, Lu E, Gleason C, Mack T, Mora J, Surapaneni S
Clin Pharmacol Ther, 114(3):664-672, 09 Aug 2023
Cited by: 2 articles | PMID: 37422675
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PK/PD and Bioanalytical Considerations of AAV-Based Gene Therapies: an IQ Consortium Industry Position Paper.
Kavita U, Sun K, Braun M, Lembke W, Mody H, Kamerud J, Yang TY, Braun IV, Fang X, Gao W, Gupta S, Hofer M, Liao MZ, Loo L, McBlane F, Menochet K, Stubenrauch KG, Upreti VV, Vigil A, [...] Chemuturi N
AAPS J, 25(5):78, 31 Jul 2023
Cited by: 2 articles | PMID: 37523051
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2022 White Paper on Recent Issues in Bioanalysis: FDA Draft Guidance on Immunogenicity Information in Prescription Drug Labeling, LNP & Viral Vectors Therapeutics/Vaccines Immunogenicity, Prolongation Effect, ADA Affinity, Risk-based Approaches, NGS, qPCR, ddPCR Assays (Part 3 - Recommendations on Gene Therapy, Cell Therapy, Vaccines Immunogenicity & Technologies; Immunogenicity & Risk Assessment of Biotherapeutics and Novel Modalities; NAb Assays Integrated Approach).
Pan L, Mora J, Walravens K, Wagner L, Hopper S, Loo L, Bettoun D, Bond S, Dessy F, Downing S, Garofolo F, Gupta S, Henderson N, Irwin C, Ishii-Watabe A, Kar S, Jawa V, Joseph J, Malvaux L, [...] Zhou L
Bioanalysis, 15(14):773-814, 01 Jul 2023
Cited by: 3 articles | PMID: 37526071
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Understanding preclinical and clinical immunogenicity risks in novel biotherapeutics development.
Sauna ZE, Jawa V, Balu-Iyer S, Chirmule N
Front Immunol, 14:1151888, 12 May 2023
Cited by: 1 article | PMID: 37251396 | PMCID: PMC10213690
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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.
Gokemeijer J, Wen Y, Jawa V, Mitra-Kaushik S, Chung S, Goggins A, Kumar S, Lamberth K, Liao K, Lill J, Phung Q, Walsh R, Roberts BJ, Swanson M, Singh I, Tourdot S, Kroenke MA, Rup B, Goletz TJ, [...] Pattijn S
AAPS J, 25(4):55, 02 Jun 2023
Cited by: 6 articles | PMID: 37266912
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Evaluation of Cellular Immune Response to Adeno-Associated Virus-Based Gene Therapy.
Gorovits B, Azadeh M, Buchlis G, Fiscella M, Harrison T, Havert M, Janetzki S, Jawa V, Long B, Mahnke YD, McDermott A, Milton M, Nelson R, Vettermann C, Wu B
AAPS J, 25(3):47, 26 Apr 2023
Cited by: 6 articles | PMID: 37101079 | PMCID: PMC10132926
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Comparison of Pre-existing Anti-AAV8 Total Antibody Screening and Confirmatory Assays with a Cell-Based Neutralizing Assay in Normal Human Serum.
Dai Y, Dong H, Gleason C, Mora J, Kolaitis G, Balasubramanian N, Surapaneni S, Kozhich A, Jawa V
AAPS J, 25(3):35, 03 Apr 2023
Cited by: 6 articles | PMID: 37012501
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An Overview of Current Accomplishments and Gaps of COVID-19 Vaccine Platforms and Considerations for Next Generation Vaccines.
Kale A, Gaur A, Menon I, Chirmule N, Bagwe P, Jawa R, Vijayanand S, Patil S, Suresh S, Jawa V
J Pharm Sci, 112(5):1345-1350, 02 Feb 2023
Cited by: 2 articles | PMID: 36736775 | PMCID: PMC9891786
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Immunogenicity assessment of AAV-based gene therapies: An IQ consortium industry white paper.
Yang TY, Braun M, Lembke W, McBlane F, Kamerud J, DeWall S, Tarcsa E, Fang X, Hofer L, Kavita U, Upreti VV, Gupta S, Loo L, Johnson AJ, Chandode RK, Stubenrauch KG, Vinzing M, Xia CQ, Jawa V
Mol Ther Methods Clin Dev, 26:471-494, 02 Aug 2022
Cited by: 17 articles | PMID: 36092368 | PMCID: PMC9418752
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Immunogenicity Risk Assessment of Spontaneously Occurring Therapeutic Monoclonal Antibody Aggregates.
Swanson MD, Rios S, Mittal S, Soder G, Jawa V
Front Immunol, 13:915412, 27 Jul 2022
Cited by: 4 articles | PMID: 35967308 | PMCID: PMC9364768
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Comparison of Titer and Signal to Noise (S/N) for Determination of Anti-drug Antibody Magnitude Using Clinical Data from an Industry Consortium.
Starcevic Manning M, Hassanein M, Partridge MA, Jawa V, Mora J, Ryman J, Barker B, Braithwaite C, Carleton K, Hay L, Hottenstein C, Kubiak RJ, Devanarayan V
AAPS J, 24(4):81, 12 Jul 2022
Cited by: 6 articles | PMID: 35821280
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2021 White Paper on Recent Issues in Bioanalysis: TAb/NAb, Viral Vector CDx, Shedding Assays; CRISPR/Cas9 & CAR-T Immunogenicity; PCR & Vaccine Assay Performance; ADA Assay Comparability & Cut Point Appropriateness (Part 3 - Recommendations on Gene Therapy, Cell Therapy, Vaccine Assays; Immunogenicity of Biotherapeutics and Novel Modalities; Integrated Summary of Immunogenicity Harmonization).
Loo L, Harris S, Milton M, Meena, Lembke W, Berisha F, Bertholet S, Dessy F, Dodge R, Fang X, Fiscella M, Garofolo F, Gorovits B, Gupta S, Jawa V, Ishii-Watabe A, Long B, Lu Y, Mack T, [...] Zhang L
Bioanalysis, 14(11):737-793, 17 May 2022
Cited by: 7 articles | PMID: 35578991
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Holistic analytical characterization and risk assessment of residual host cell protein impurities in an active pharmaceutical ingredient synthesized by biocatalysts.
Wang F, Li X, Swanson M, Guetschow E, Winston M, Smith JP, Hoyt E, Liu Z, Richardson D, Bu X, Jawa V, Variankaval N
Biotechnol Bioeng, 119(8):2088-2104, 04 May 2022
Cited by: 1 article | PMID: 35437754
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When to Extend Monitoring of Anti-drug Antibodies for High-risk Biotherapeutics in Clinical Trials: an Opinion from the European Immunogenicity Platform.
Lotz GP, Benstein K, Bloem K, Buddiger H, Calonder C, Elm S, Fernandez E, Goodman J, Gorovits B, Grudzinska-Goebel J, Janssen M, Jawa V, Kramer D, Luo L, Malisauskas M, Michaut L, Schäfer M, Spindeldreher S, Ullmann M, [...] Snoeck V
AAPS J, 24(3):68, 12 May 2022
Cited by: 1 article | PMID: 35554731
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Use of In Vitro Human Skin Models to Assess Potential Immune Activation In Response to Biotherapeutic Attributes and Process-related Impurities.
Tokuda JM, Xie J, Jawa V, Hawkins JM, Ferbas J, Joh NH, Joubert MK
J Pharm Sci, 111(4):1012-1023, 06 Feb 2022
Cited by: 3 articles | PMID: 35139332
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Prevalence of Pre-Existing Neutralizing Antibodies Against Adeno-Associated Virus Serotypes 1, 2, 5, 6, 8, and 9 in Sera of Different Pig Strains.
Dai Y, Kavita U, Lampen MH, Gielen S, Banks G, Levesque P, Kozhich A, Pillutla R, Zhang Y, Jawa V, Adam L
Hum Gene Ther, 33(7-8):451-459, 01 Apr 2022
Cited by: 6 articles | PMID: 34913759
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Holistic Analytical Characterization and Risk Assessment of Residual Host Cell Protein Impurities in an Active Pharmaceutical Ingredient (API) Synthesized by Biocatalysts
Wang F, LI X, Swanson M, Guetschow E, Winston M, Smith JP, Hoyt E, Liu Z, Richardson D, Bu X, Jawa V, Variankaval N
Authorea Preprints, 30 Jan 2022
Cited by: 0 articles | PPR: PPR448277
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