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1.
A High Threshold of Biotherapeutic Aggregate Numbers is Needed to Induce an Immunogenic Response In Vitro, In Vivo, and in the Clinic.
Pharm Res;
41(4): 651-672, 2024 Apr.
Artículo
en Inglés
| MEDLINE | ID: mdl-38519817
2.
Holistic analytical characterization and risk assessment of residual host cell protein impurities in an active pharmaceutical ingredient synthesized by biocatalysts.
Biotechnol Bioeng;
119(8): 2088-2104, 2022 08.
Artículo
en Inglés
| MEDLINE | ID: mdl-35437754
3.
Assessment of romiplostim immunogenicity in adult patients in clinical trials and in a global postmarketing registry.
Br J Haematol;
190(6): 923-932, 2020 09.
Artículo
en Inglés
| MEDLINE | ID: mdl-32311075
4.
Chemical and Biophysical Characteristics of Monoclonal Antibody Solutions Containing Aggregates Formed during Metal Catalyzed Oxidation.
Pharm Res;
34(12): 2817-2828, 2017 Dec.
Artículo
en Inglés
| MEDLINE | ID: mdl-29110285
5.
An IQ Consortium Perspective on Best Practices for Bioanalytical and Immunogenicity Assessment Aspects of CAR-T and TCR-T Cellular Therapies Development.
Clin Pharmacol Ther;
115(2): 188-200, 2024 02.
Artículo
en Inglés
| MEDLINE | ID: mdl-37983584
6.
Immunogenicity Risk Assessment of Process-Related Impurities in An Engineered T Cell Receptor Cellular Product.
J Pharm Sci;
2024 May 18.
Artículo
en Inglés
| MEDLINE | ID: mdl-38768755
7.
Preexisting antibody assays for gene therapy: Considerations on patient selection cutoffs and companion diagnostic requirements.
Mol Ther Methods Clin Dev;
32(1): 101217, 2024 Mar 14.
Artículo
en Inglés
| MEDLINE | ID: mdl-38496304
8.
Highly aggregated antibody therapeutics can enhance the in vitro innate and late-stage T-cell immune responses.
J Biol Chem;
287(30): 25266-79, 2012 Jul 20.
Artículo
en Inglés
| MEDLINE | ID: mdl-22584577
9.
T-cell dependent immunogenicity of protein therapeutics: Preclinical assessment and mitigation.
Clin Immunol;
149(3): 534-55, 2013 Dec.
Artículo
en Inglés
| MEDLINE | ID: mdl-24263283
10.
Unexpected thrombocytopenia and anemia in cynomolgus monkeys induced by a therapeutic human monoclonal antibody.
Toxicol Pathol;
41(7): 951-69, 2013.
Artículo
en Inglés
| MEDLINE | ID: mdl-23475561
11.
Understanding preclinical and clinical immunogenicity risks in novel biotherapeutics development.
Front Immunol;
14: 1151888, 2023.
Artículo
en Inglés
| MEDLINE | ID: mdl-37251396
12.
An Overview of Current Accomplishments and Gaps of COVID-19 Vaccine Platforms and Considerations for Next Generation Vaccines.
J Pharm Sci;
112(5): 1345-1350, 2023 05.
Artículo
en Inglés
| MEDLINE | ID: mdl-36736775
13.
Comparison of Pre-existing Anti-AAV8 Total Antibody Screening and Confirmatory Assays with a Cell-Based Neutralizing Assay in Normal Human Serum.
AAPS J;
25(3): 35, 2023 04 03.
Artículo
en Inglés
| MEDLINE | ID: mdl-37012501
14.
Bioanalytical Methods for Characterization of CAR-T Cellular Kinetics: Comparison of PCR Assays and Matrices.
Clin Pharmacol Ther;
114(3): 664-672, 2023 09.
Artículo
en Inglés
| MEDLINE | ID: mdl-37422675
15.
Best Practices and Considerations for Clinical Pharmacology and Pharmacometric Aspects for Optimal Development of CAR-T and TCR-T Cell Therapies: An Industry Perspective.
Clin Pharmacol Ther;
114(3): 530-557, 2023 09.
Artículo
en Inglés
| MEDLINE | ID: mdl-37393588
16.
Evaluation of Cellular Immune Response to Adeno-Associated Virus-Based Gene Therapy.
AAPS J;
25(3): 47, 2023 04 26.
Artículo
en Inglés
| MEDLINE | ID: mdl-37101079
17.
Survey Outcome on Immunogenicity Risk Assessment Tools for Biotherapeutics: an Insight into Consensus on Methods, Application, and Utility in Drug Development.
AAPS J;
25(4): 55, 2023 06 02.
Artículo
en Inglés
| MEDLINE | ID: mdl-37266912
18.
PK/PD and Bioanalytical Considerations of AAV-Based Gene Therapies: an IQ Consortium Industry Position Paper.
AAPS J;
25(5): 78, 2023 07 31.
Artículo
en Inglés
| MEDLINE | ID: mdl-37523051
19.
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).
Bioanalysis;
15(14): 773-814, 2023 Jul.
Artículo
en Inglés
| MEDLINE | ID: mdl-37526071
20.
Implementing a Clinical Immunogenicity Strategy using Preclinical Risk Assessment Outputs.
J Pharm Sci;
111(4): 960-969, 2022 04.
Artículo
en Inglés
| MEDLINE | ID: mdl-35122828