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1.
Overcoming Lot-to-Lot Variability in Protein Activity Using Epitope-Specific Calibration-Free Concentration Analysis.
Anal Chem
; 96(16): 6275-6281, 2024 Apr 23.
Artículo
en Inglés
| MEDLINE | ID: mdl-38600735
2.
The impact of ligand binding based assays critical reagent characterization and storage.
Bioanalysis
; 13(10): 797-805, 2021 May.
Artículo
en Inglés
| MEDLINE | ID: mdl-34002637
3.
2019 White Paper on Recent Issues in Bioanalysis: FDA Immunogenicity Guidance, Gene Therapy, Critical Reagents, Biomarkers and Flow Cytometry Validation (Part 3 - Recommendations on 2019 FDA Immunogenicity Guidance, Gene Therapy Bioanalytical Challenges, Strategies for Critical Reagent Management, Biomarker Assay Validation, Flow Cytometry Validation & CLSI H62).
Bioanalysis
; 11(24): 2207-2244, 2019 Dec.
Artículo
en Inglés
| MEDLINE | ID: mdl-31820675
4.
Surface plasmon resonance as a tool for ligand-binding assay reagent characterization in bioanalysis of biotherapeutics.
Bioanalysis
; 10(8): 559-576, 2018 Apr 01.
Artículo
en Inglés
| MEDLINE | ID: mdl-29701071
5.
2018 White Paper on Recent Issues in Bioanalysis: focus on flow cytometry, gene therapy, cut points and key clarifications on BAV (Part 3 - LBA/cell-based assays: immunogenicity, biomarkers and PK assays).
Bioanalysis
; 10(24): 1973-2001, 2018 Dec.
Artículo
en Inglés
| MEDLINE | ID: mdl-30488726
6.
Real-time observation of protein aggregates in pharmaceutical formulations using liquid cell electron microscopy.
Lab Chip
; 17(2): 315-322, 2017 01 17.
Artículo
en Inglés
| MEDLINE | ID: mdl-27934977
7.
Singlicate Ligand Binding Assay Using an Automated Microfluidic System: a Clinical Case Study.
AAPS J
; 19(5): 1461-1468, 2017 09.
Artículo
en Inglés
| MEDLINE | ID: mdl-28589510
8.
2017 White Paper on recent issues in bioanalysis: a global perspective on immunogenicity guidelines & biomarker assay performance (Part 3 - LBA: immunogenicity, biomarkers and PK assays).
Bioanalysis
; 9(24): 1967-1996, 2017 Dec.
Artículo
en Inglés
| MEDLINE | ID: mdl-29205064
9.
Development and characterization of a pre-treatment procedure to eliminate human monoclonal antibody therapeutic drug and matrix interference in cell-based functional neutralizing antibody assays.
J Immunol Methods
; 416: 94-104, 2015 Jan.
Artículo
en Inglés
| MEDLINE | ID: mdl-25445325
10.
Development and Fit-for-Purpose Validation of a Soluble Human Programmed Death-1 Protein Assay.
AAPS J
; 17(4): 976-87, 2015 Jul.
Artículo
en Inglés
| MEDLINE | ID: mdl-25924887
11.
Conjugated critical reagent characterization for ligand-binding assays: using MALDI-TOF-MS as an orthogonal tool to assess assay performance.
Bioanalysis
; 6(7): 983-92, 2014 Apr.
Artículo
en Inglés
| MEDLINE | ID: mdl-24806906
12.
Targeting an acid labile aspartyl-prolyl amide bond as a viable alternative to trypsin digestion to generate a surrogate peptide for LC-MS/MS analysis.
Bioanalysis
; 6(22): 2985-98, 2014.
Artículo
en Inglés
| MEDLINE | ID: mdl-25496253
13.
Development of a validated liquid chromatography tandem mass spectrometry assay for a PEGylated adnectin in cynomolgus monkey plasma using protein precipitation and trypsin digestion.
J Chromatogr B Analyt Technol Biomed Life Sci
; 934: 1-7, 2013 Sep 01.
Artículo
en Inglés
| MEDLINE | ID: mdl-23891912
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