Detalhe da pesquisa
1.
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.
Artigo
em Inglês
| MEDLINE | ID: mdl-35578991
2.
Anti-drug Antibody Validation Testing and Reporting Harmonization.
AAPS J
; 24(1): 4, 2021 12 01.
Artigo
em Inglês
| MEDLINE | ID: mdl-34853961
3.
Tissue distribution of 35S-metabolically labeled neublastin (BG00010) in rats.
J Pharm Biomed Anal
; 184: 113154, 2020 May 30.
Artigo
em Inglês
| MEDLINE | ID: mdl-32097771
4.
Recommendations for the Development of Cell-Based Anti-Viral Vector Neutralizing Antibody Assays.
AAPS J
; 22(2): 24, 2020 01 06.
Artigo
em Inglês
| MEDLINE | ID: mdl-31907680
5.
Correction to: Recommendations for the Development of Cell-Based Anti-Viral Vector Neutralizing Antibody Assays.
AAPS J
; 22(2): 42, 2020 Feb 04.
Artigo
em Inglês
| MEDLINE | ID: mdl-32020345
6.
Well-developed ligand-binding assays demonstrate robust performance using singlet analysis.
Bioanalysis
; 11(22): 2075-2086, 2019 Nov.
Artigo
em Inglês
| MEDLINE | ID: mdl-31829740
7.
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.
Artigo
em Inglês
| MEDLINE | ID: mdl-31820675
8.
Emerging technologies for biotherapeutic bioanalysis from a high-throughput and multiplexing perspective: insights from an AAPS emerging technology action program committee.
Bioanalysis
; 10(3): 181-194, 2018 Feb.
Artigo
em Inglês
| MEDLINE | ID: mdl-29345151
9.
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.
Artigo
em Inglês
| MEDLINE | ID: mdl-30488726
10.
Development of a plug and play ImmunoPCR technique for the analysis of biomolecules.
Bioanalysis
; 9(17): 1293-1303, 2017 Sep.
Artigo
em Inglês
| MEDLINE | ID: mdl-28901160
11.
Recommendations for the Assessment and Management of Pre-existing Drug-Reactive Antibodies During Biotherapeutic Development.
AAPS J
; 19(6): 1576-1586, 2017 11.
Artigo
em Inglês
| MEDLINE | ID: mdl-29110222
12.
Emerging Technologies and Generic Assays for the Detection of Anti-Drug Antibodies.
J Immunol Res
; 2016: 6262383, 2016.
Artigo
em Inglês
| MEDLINE | ID: mdl-27556048
13.
Pre-existing Antibody: Biotherapeutic Modality-Based Review.
AAPS J
; 18(2): 311-20, 2016 Mar.
Artigo
em Inglês
| MEDLINE | ID: mdl-26821802
14.
Evaluation of highly sensitive immunoassay technologies for quantitative measurements of sub-pg/mL levels of cytokines in human serum.
J Immunol Methods
; 437: 53-63, 2016 10.
Artigo
em Inglês
| MEDLINE | ID: mdl-27555238
15.
Parallelism: considerations for the development, validation and implementation of PK and biomarker ligand-binding assays.
Bioanalysis
; 6(2): 185-98, 2014 Jan.
Artigo
em Inglês
| MEDLINE | ID: mdl-24423595
16.
Next generation ligand binding assays-review of emerging technologies' capabilities to enhance throughput and multiplexing.
AAPS J
; 16(6): 1175-84, 2014 Nov.
Artigo
em Inglês
| MEDLINE | ID: mdl-25193269
17.
Biomarker assays: is it time for a standalone regulatory guidance?
Bioanalysis
; 10(23): 1893-1895, 2018 Dec.
Artigo
em Inglês
| MEDLINE | ID: mdl-30442025
18.
Parallelism: the foundation of biomarker assay development and validation.
Bioanalysis
; 10(12): 897-899, 2018 06 01.
Artigo
em Inglês
| MEDLINE | ID: mdl-29923751
19.
Bioanalysis of antibody-drug conjugates: American Association of Pharmaceutical Scientists Antibody-Drug Conjugate Working Group position paper.
Bioanalysis
; 5(9): 997-1006, 2013 May.
Artigo
em Inglês
| MEDLINE | ID: mdl-23641692
20.
Recent Advances in Assessing Immunogenicity of Therapeutic Proteins: Impact on Biotherapeutic Development.
J Immunol Res
; 2016: 8141269, 2016.
Artigo
em Inglês
| MEDLINE | ID: mdl-27642612