Detalles de la búsqueda
1.
Simple and Sensitive Method for Deep Profiling of Host Cell Proteins in Therapeutic Antibodies by Combining Ultra-Low Trypsin Concentration Digestion, Long Chromatographic Gradients, and BoxCar Mass Spectrometry Acquisition.
Anal Chem
; 93(10): 4383-4390, 2021 03 16.
Artículo
en Inglés
| MEDLINE | ID: mdl-33656852
2.
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
3.
Antidrug Antibodies in Patients Treated with Alirocumab.
N Engl J Med
; 376(16): 1589-90, 2017 04 20.
Artículo
en Inglés
| MEDLINE | ID: mdl-28304229
4.
Kinetics of Trisulfide-to-Disulfide Conversion of Therapeutic IgG1 Monoclonal Antibodies Under Physiological Conditions: A Case Study of Casirivimab And Imdevimab.
J Pharm Sci
; 113(3): 642-646, 2024 03.
Artículo
en Inglés
| MEDLINE | ID: mdl-37913905
5.
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
6.
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
7.
2022 White Paper on Recent Issues in Bioanalysis: FDA Draft Guidance on Immunogenicity Information in Prescription Drug Labeling, LNP & Viral Vectors Therapeutics/Vaccines Immunogenicity, Prolongation Effect, ADA Affinity,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
8.
Interference in a Neutralizing Antibody Assay for Odronextamab, a CD20xCD3 Bispecific mAb, from Prior Rituximab Therapy and Possible Mitigation Strategy.
AAPS J
; 24(4): 76, 2022 06 21.
Artículo
en Inglés
| MEDLINE | ID: mdl-35725847
9.
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
10.
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
11.
2021 White Paper on Recent Issues in Bioanalysis: ISR for Biomarkers, Liquid Biopsies, Spectral Cytometry, Inhalation/Oral & Multispecific Biotherapeutics, Accuracy/LLOQ for Flow Cytometry (Part 2 - Recommendations on Biomarkers/CDx Assays Development & Validation, Cytometry Validation & Innovation, Biotherapeutics PK LBA Regulated Bioanalysis, Critical Reagents & Positive Controls Generation).
Bioanalysis
; 14(10): 627-692, 2022 May.
Artículo
en Inglés
| MEDLINE | ID: mdl-35578974
12.
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
13.
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
14.
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
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.
Assessment of clinically relevant immunogenicity for mAbs; are we over reporting ADA?
Bioanalysis
; 12(18): 1325-1336, 2020 09.
Artículo
en Inglés
| MEDLINE | ID: mdl-32946271
17.
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
18.
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
19.
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
20.
Immunogenicity of Sarilumab Monotherapy in Patients with Rheumatoid Arthritis Who Were Inadequate Responders or Intolerant to Disease-Modifying Antirheumatic Drugs.
Rheumatol Ther
; 6(3): 339-352, 2019 Sep.
Artículo
en Inglés
| MEDLINE | ID: mdl-31090044