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1.
Human Monoclonal Antibody Cocktail for the Treatment or Prophylaxis of Middle East Respiratory Syndrome Coronavirus.
J Infect Dis
; 225(10): 1765-1772, 2022 05 16.
Artículo
en Inglés
| MEDLINE | ID: mdl-33507266
2.
Baseline Severe Acute Respiratory Syndrome Viral Load Is Associated With Coronavirus Disease 2019 Severity and Clinical Outcomes: Post Hoc Analyses of a Phase 2/3 Trial.
J Infect Dis
; 224(11): 1830-1838, 2021 12 01.
Artículo
en Inglés
| MEDLINE | ID: mdl-34496013
3.
Liquid Chromatography-Multiple Reaction Monitoring-Mass Spectrometry Assay for Quantitative Measurement of Therapeutic Antibody Cocktail REGEN-COV Concentrations in COVID-19 Patient Serum.
Anal Chem
; 93(38): 12889-12898, 2021 09 28.
Artículo
en Inglés
| MEDLINE | ID: mdl-34463470
4.
Immunogenicity of Cemiplimab: Low Incidence of Antidrug Antibodies and Cut-Point Suitability Across Tumor Types.
J Clin Pharmacol
; 64(1): 125-136, 2024 Jan.
Artículo
en Inglés
| MEDLINE | ID: mdl-37656820
5.
Statistical Approaches for Establishing Appropriate Immunogenicity Assay Cut Points: Impact of Sample Distribution, Sample Size, and Outlier Removal.
AAPS J
; 25(3): 37, 2023 04 04.
Artículo
en Inglés
| MEDLINE | ID: mdl-37016171
6.
2022 White Paper on Recent Issues in Bioanalysis: Enzyme Assay Validation, BAV for Primary End Points, Vaccine Functional Assays, Cytometry in Tissue, LBA in Rare Matrices, Complex NAb Assays, Spectral Cytometry, Endogenous Analytes, Extracellular Vesicles Part 2 - Recommendations on Biomarkers/CDx, Flow Cytometry, Ligand-Binding Assays Development & Validation; Emerging Technologies; Critical Reagents Deep Characterization.
Bioanalysis
; 15(15): 861-903, 2023 Aug.
Artículo
en Inglés
| MEDLINE | ID: mdl-37584363
7.
Assay pH and critical reagent optimization in measuring concentrations of a monoclonal antibody and its target.
Bioanalysis
; 14(8): 491-502, 2022 Apr.
Artículo
en Inglés
| MEDLINE | ID: mdl-35297286
8.
Pre-existing Reactivity to an IgG4 Fc-Epitope: Characterization and Mitigation of Interference in a Bridging Anti-drug Antibody Assay.
AAPS J
; 24(4): 78, 2022 07 01.
Artículo
en Inglés
| MEDLINE | ID: mdl-35778641
9.
2021 White Paper on Recent Issues in Bioanalysis: Mass Spec of Proteins, Extracellular Vesicles, CRISPR, Chiral Assays, Oligos; Nanomedicines Bioanalysis; ICH M10 Section 7.1; Non-Liquid & Rare Matrices; Regulatory Inputs (Part 1A - Recommendations on Endogenous Compounds, Small Molecules, Complex Methods, Regulated Mass Spec of Large Molecules, Small Molecule, PoC & Part 1B - Regulatory Agencies' Inputs on Bioanalysis, Biomarkers, Immunogenicity, Gene & Cell Therapy and Vaccine).
Bioanalysis
; 14(9): 505-580, 2022 May.
Artículo
en Inglés
| MEDLINE | ID: mdl-35578993
10.
Quantitation of reduced IL-33 levels in human serum: mitigating interference from endogenous binding partners.
Bioanalysis
; 13(23): 1751-1760, 2021 Dec.
Artículo
en Inglés
| MEDLINE | ID: mdl-34758642
11.
Isotyping and Semi-Quantitation of Monkey Anti-Drug Antibodies by Immunocapture Liquid Chromatography-Mass Spectrometry.
AAPS J
; 23(1): 16, 2021 01 06.
Artículo
en Inglés
| MEDLINE | ID: mdl-33404777
12.
Bioanalytical Challenges due to Prior Checkpoint Inhibitor Exposure: Interference and Mitigation in Drug Concentration and Immunogenicity Assays.
AAPS J
; 23(6): 109, 2021 10 04.
Artículo
en Inglés
| MEDLINE | ID: mdl-34608545
13.
REGEN-COV® antibody cocktail bioanalytical strategy: comparison of LC-MRM-MS and immunoassay methods for drug quantification.
Bioanalysis
; 13(24): 1827-1836, 2021 Dec.
Artículo
en Inglés
| MEDLINE | ID: mdl-34743612
14.
2020 White Paper on Recent Issues in Bioanalysis: BAV Guidance, CLSI H62, Biotherapeutics Stability, Parallelism Testing, CyTOF and Regulatory Feedback (Part 2A - Recommendations on Biotherapeutics Stability, PK LBA Regulated Bioanalysis, Biomarkers Assays, Cytometry Validation & Innovation Part 2B - Regulatory Agencies' Inputs on Bioanalysis, Biomarkers, Immunogenicity, Gene & Cell Therapy and Vaccine).
Bioanalysis
; 13(5): 295-361, 2021 Mar.
Artículo
en Inglés
| MEDLINE | ID: mdl-33511867
15.
Overcoming multimeric target interference in a bridging immunogenicity assay with soluble target receptor, target immunodepletion and mild acidic assay pH.
Bioanalysis
; 12(15): 1071-1085, 2020 Aug.
Artículo
en Inglés
| MEDLINE | ID: mdl-32735128
16.
Drug Removal Strategies in Competitive Ligand Binding Neutralizing Antibody (NAb) Assays: Highly Drug-Tolerant Methods and Interpreting Immunogenicity Data.
AAPS J
; 22(5): 112, 2020 08 17.
Artículo
en Inglés
| MEDLINE | ID: mdl-32808205
17.
Anti-VEGF drug interference with VEGF quantitation in the R&D systems human quantikine VEGF ELISA kit.
Bioanalysis
; 11(5): 381-392, 2019 Mar.
Artículo
en Inglés
| MEDLINE | ID: mdl-30892063
18.
Mitigating target interference in bridging immunogenicity assay with target-blocking reagents and mild basic pH.
Bioanalysis
; 11(17): 1569-1580, 2019 Sep.
Artículo
en Inglés
| MEDLINE | ID: mdl-31208197
19.
Safety, pharmacokinetics, and immunogenicity of a co-formulated cocktail of three human monoclonal antibodies targeting Ebola virus glycoprotein in healthy adults: a randomised, first-in-human phase 1 study.
Lancet Infect Dis
; 18(8): 884-893, 2018 08.
Artículo
en Inglés
| MEDLINE | ID: mdl-29929783
20.
Drug Target Interference in Immunogenicity Assays: Recommendations and Mitigation Strategies.
AAPS J
; 19(6): 1564-1575, 2017 11.
Artículo
en Inglés
| MEDLINE | ID: mdl-29063411