Detalhe da pesquisa
1.
High-Throughput, Sensitive LC-MS Quantification of Biotherapeutics and Biomarkers Using Antibody-Free, Peptide-Level, Multiple-Mechanism Enrichment via Strategic Regulation of pH and Ionic and Solvent Strengths.
Anal Chem
; 91(5): 3475-3483, 2019 03 05.
Artigo
em Inglês
| MEDLINE | ID: mdl-30712341
2.
Are Biotransformation Studies of Therapeutic Proteins Needed? Scientific Considerations and Technical Challenges.
Drug Metab Dispos
; 47(12): 1443-1456, 2019 12.
Artigo
em Inglês
| MEDLINE | ID: mdl-31748266
3.
Generation, Characterization, and Quantitative Bioanalysis of Drug/Anti-drug Antibody Immune Complexes to Facilitate Dedicated In Vivo Studies.
Pharm Res
; 36(9): 129, 2019 Jun 28.
Artigo
em Inglês
| MEDLINE | ID: mdl-31254106
4.
In Vivo Biotransformation of the Fusion Protein Tetranectin-Apolipoprotein A1 Analyzed by Ligand-Binding Mass Spectrometry Combined with Quantitation by ELISA.
Anal Chem
; 88(23): 11670-11677, 2016 12 06.
Artigo
em Inglês
| MEDLINE | ID: mdl-27934109
5.
Biodistribution of Drug/ADA Complexes: The Impact of Immune Complex Formation on Antibody Distribution.
AAPS J
; 26(2): 33, 2024 Mar 13.
Artigo
em Inglês
| MEDLINE | ID: mdl-38478197
6.
Phase 1, first-in-human study of TYRP1-TCB (RO7293583), a novel TYRP1-targeting CD3 T-cell engager, in metastatic melanoma: active drug monitoring to assess the impact of immune response on drug exposure.
Front Oncol
; 14: 1346502, 2024.
Artigo
em Inglês
| MEDLINE | ID: mdl-38577337
7.
Direct bioanalysis or indirect calculation of target engagement and free drug exposure: do we apply double standards?
Bioanalysis
; 15(1): 5-16, 2023 Jan.
Artigo
em Inglês
| MEDLINE | ID: mdl-36762451
8.
High ionic strength dissociation assay reduces dimeric target interference in immunogenicity testing.
Bioanalysis
; 15(14): 823-832, 2023 Jul.
Artigo
em Inglês
| MEDLINE | ID: mdl-37326333
9.
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.
Artigo
em Inglês
| MEDLINE | ID: mdl-37584363
10.
Development of tetravalent IgG1 dual targeting IGF-1R-EGFR antibodies with potent tumor inhibition.
Arch Biochem Biophys
; 526(2): 206-18, 2012 Oct 15.
Artigo
em Inglês
| MEDLINE | ID: mdl-22464987
11.
Novel isoelectric target depletion (ITaD) protocol reduces the need for specific reagents for immunogenicity testing.
Bioanalysis
; 14(10): 725-735, 2022 May.
Artigo
em Inglês
| MEDLINE | ID: mdl-35642540
12.
Validation of a method to analyze size distribution of crovalimab-complement C5-eculizumab complexes in human serum.
Bioanalysis
; 14(13): 935-947, 2022 Jul.
Artigo
em Inglês
| MEDLINE | ID: mdl-35904159
13.
Comparison of assay formats used for the detection of pre-existing anti-drug antibodies against monoclonal antibodies.
Bioanalysis
; 14(13): 923-933, 2022 Jul.
Artigo
em Inglês
| MEDLINE | ID: mdl-36066084
14.
Conference Report from the European Bioanalysis Forum Workshop: toward harmonized implementation of the ICH M10 guideline.
Bioanalysis
; 14(22): 1407-1411, 2022 Nov.
Artigo
em Inglês
| MEDLINE | ID: mdl-36705021
15.
An Alternative Data Transformation Approach for ADA Cut Point Determination: Why Not Use a Weibull Transformation?
AAPS J
; 23(5): 97, 2021 08 13.
Artigo
em Inglês
| MEDLINE | ID: mdl-34389881
16.
Increasing robustness, reliability and storage stability of critical reagents by freeze-drying.
Bioanalysis
; 13(10): 829-840, 2021 May.
Artigo
em Inglês
| MEDLINE | ID: mdl-33890493
17.
The impact of immunogenicity on therapeutic antibody pharmacokinetics: A preclinical evaluation of the effect of immune complex formation and antibody effector function on clearance.
MAbs
; 13(1): 1995929, 2021.
Artigo
em Inglês
| MEDLINE | ID: mdl-34763611
18.
Recommendations and discussion points on immunogenicity, biomarkers, automation/technology and protein-MS from the 2021 European Bioanalysis Forum Focus Workshops.
Bioanalysis
; 13(19): 1459-1465, 2021 Oct.
Artigo
em Inglês
| MEDLINE | ID: mdl-34605275
19.
2020 White Paper on Recent Issues in Bioanalysis: Vaccine Assay Validation, qPCR Assay Validation, QC for CAR-T Flow Cytometry, NAb Assay Harmonization and ELISpot Validation (Part 3 - Recommendations on Immunogenicity Assay Strategies, NAb Assays, Biosimilars and FDA/EMA Immunogenicity Guidance/Guideline, Gene & Cell Therapy and Vaccine Assays).
Bioanalysis
; 13(6): 415-463, 2021 Mar.
Artigo
em Inglês
| MEDLINE | ID: mdl-33533276
20.
Toward comparability of anti-drug antibody assays: is the amount of anti-drug antibody-reagent complexes at cut-point (CP-ARC) the missing piece?
Bioanalysis
; 12(14): 1021-1031, 2020 Jul.
Artigo
em Inglês
| MEDLINE | ID: mdl-32633539