Detalles de la búsqueda
1.
Proceedings of the 14th European immunogenicity platform open symposium on immunogenicity of biopharmaceuticals.
MAbs
; 16(1): 2324801, 2024.
Artículo
en Inglés
| MEDLINE | ID: mdl-38441119
2.
Neutralizing Antibody Validation Testing and Reporting Harmonization.
AAPS J
; 25(4): 69, 2023 07 08.
Artículo
en Inglés
| MEDLINE | ID: mdl-37421491
3.
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
4.
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.
Artículo
en Inglés
| MEDLINE | ID: mdl-33533276
5.
Anti-drug Antibody Validation Testing and Reporting Harmonization.
AAPS J
; 24(1): 4, 2021 12 01.
Artículo
en Inglés
| MEDLINE | ID: mdl-34853961
6.
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
7.
The IP10 (CXCL10) specific cDNA probe of the mCK-5c multiprobe RNase protection assay kit carries two nucleotide insertions that complicate the interpretation of results.
Cytokine
; 41(2): 182-6, 2008 Feb.
Artículo
en Inglés
| MEDLINE | ID: mdl-18226543
8.
Evaluating and Mitigating the Immunogenicity of Therapeutic Proteins.
Trends Biotechnol
; 36(10): 1068-1084, 2018 10.
Artículo
en Inglés
| MEDLINE | ID: mdl-29908714
9.
Feedback from the European Bioanalysis Forum: focus workshop on current analysis of immunogenicity: best practices and regulatory hurdles.
Bioanalysis
; 10(4): 197-204, 2018 Feb.
Artículo
en Inglés
| MEDLINE | ID: mdl-29345496
10.
2018 White Paper on Recent Issues in Bioanalysis: focus on immunogenicity assays by hybrid LBA/LCMS and regulatory feedback (Part 2 - PK, PD & ADA assays by hybrid LBA/LCMS & regulatory agencies' inputs on bioanalysis, biomarkers and immunogenicity).
Bioanalysis
; 10(23): 1897-1917, 2018 Dec.
Artículo
en Inglés
| MEDLINE | ID: mdl-30488729
11.
Thermolytic CpG-containing DNA oligonucleotides as potential immunotherapeutic prodrugs.
Nucleic Acids Res
; 33(11): 3550-60, 2005.
Artículo
en Inglés
| MEDLINE | ID: mdl-15972797
12.
CD4 and CD8 T cells mediate distinct lethal meningoencephalitis in mice challenged with Tacaribe arenavirus.
Cell Mol Immunol
; 14(1): 90-107, 2017 01.
Artículo
en Inglés
| MEDLINE | ID: mdl-27569560
13.
2017 White Paper: rise of hybrid LBA/LCMS immunogenicity assays (Part 2: hybrid LBA/LCMS biotherapeutics, biomarkers & immunogenicity assays and regulatory agencies' inputs).
Bioanalysis
; 9(23): 1895-1912, 2017 Dec.
Artículo
en Inglés
| MEDLINE | ID: mdl-29205053
14.
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
15.
Strategies to Determine Assay Format for the Assessment of Neutralizing Antibody Responses to Biotherapeutics.
AAPS J
; 18(6): 1335-1350, 2016 11.
Artículo
en Inglés
| MEDLINE | ID: mdl-27495119
16.
2016 White Paper on recent issues in bioanalysis: focus on biomarker assay validation (BAV): (Part 2 - Hybrid LBA/LCMS and input from regulatory agencies).
Bioanalysis
; 8(23): 2457-2474, 2016 Dec.
Artículo
en Inglés
| MEDLINE | ID: mdl-27855509
17.
2016 White Paper on recent issues in bioanalysis: focus on biomarker assay validation (BAV): (Part 3 - LBA, biomarkers and immunogenicity).
Bioanalysis
; 8(23): 2475-2496, 2016 Dec.
Artículo
en Inglés
| MEDLINE | ID: mdl-27855512
18.
Design and development of thermolytic DNA oligonucleotide prodrugs.
Ann N Y Acad Sci
; 1058: 26-38, 2005 Nov.
Artículo
en Inglés
| MEDLINE | ID: mdl-16394123
19.
The Interleukin-13 Receptor-α1 Chain Is Essential for Induction of the Alternative Macrophage Activation Pathway by IL-13 but Not IL-4.
J Innate Immun
; 7(5): 494-505, 2015.
Artículo
en Inglés
| MEDLINE | ID: mdl-25766112
20.
Workshop Report: AAPS Workshop on Method Development, Validation, and Troubleshooting of Ligand-Binding Assays in the Regulated Environment.
AAPS J
; 17(4): 1019-24, 2015 Jul.
Artículo
en Inglés
| MEDLINE | ID: mdl-25921938