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1.
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
2.
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
3.
2022 White Paper on Recent Issues in Bioanalysis: FDA Draft Guidance on Immunogenicity Information in Prescription Drug Labeling, LNP & Viral Vectors Therapeutics/Vaccines Immunogenicity, Prolongation Effect, ADA Affinity,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
4.
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
5.
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
6.
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).
Bioanalysis
; 14(11): 737-793, 2022 Jun.
Artículo
en Inglés
| MEDLINE | ID: mdl-35578991
7.
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
8.
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
9.
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
10.
2019 White Paper On Recent Issues in Bioanalysis: FDA BMV Guidance, ICH M10 BMV Guideline and Regulatory Inputs (Part 2 - Recommendations on 2018 FDA BMV Guidance, 2019 ICH M10 BMV Draft Guideline and Regulatory Agencies' Input on Bioanalysis, Biomarkers and Immunogenicity).
Bioanalysis
; 11(23): 2099-2132, 2019 Dec.
Artículo
en Inglés
| MEDLINE | ID: mdl-31833782
11.
Open-label therapy with alirocumab in patients with heterozygous familial hypercholesterolemia: Results from three years of treatment.
Int J Cardiol
; 228: 754-760, 2017 02 01.
Artículo
en Inglés
| MEDLINE | ID: mdl-27886619
12.
Effects of blood processing and sample storage on the stability of biotherapeutics and anti-drug antibodies.
Bioanalysis
; 7(11): 1325-35, 2015.
Artículo
en Inglés
| MEDLINE | ID: mdl-26110705
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