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1.
PK/PD and Bioanalytical Considerations of AAV-Based Gene Therapies: an IQ Consortium Industry Position Paper.
AAPS J
; 25(5): 78, 2023 07 31.
Artículo
en Inglés
| MEDLINE | ID: mdl-37523051
2.
2022 White Paper on Recent Issues in Bioanalysis: FDA Draft Guidance on Immunogenicity Information in Prescription Drug Labeling, LNP & Viral Vectors Therapeutics/Vaccines Immunogenicity, Prolongation Effect, ADA Affinity,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
3.
Immunogenicity assessment of AAV-based gene therapies: An IQ consortium industry white paper.
Mol Ther Methods Clin Dev
; 26: 471-494, 2022 Sep 08.
Artículo
en Inglés
| MEDLINE | ID: mdl-36092368
4.
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
5.
Highly sensitive detection of HER2 extracellular domain in the serum of breast cancer patients by piezoelectric microcantilevers.
Anal Chem
; 83(9): 3392-7, 2011 May 01.
Artículo
en Inglés
| MEDLINE | ID: mdl-21449604
6.
The Red clover necrotic mosaic virus capsid as a multifunctional cell targeting plant viral nanoparticle.
Bioconjug Chem
; 22(1): 67-73, 2011 Jan 19.
Artículo
en Inglés
| MEDLINE | ID: mdl-21126069
7.
A rapid method to regenerate piezoelectric microcantilever sensors (PEMS).
Sensors (Basel)
; 11(5): 5520-8, 2011.
Artículo
en Inglés
| MEDLINE | ID: mdl-22413149
8.
Infusion of dye molecules into Red clover necrotic mosaic virus.
Chem Commun (Camb)
; (1): 88-90, 2008 Jan 07.
Artículo
en Inglés
| MEDLINE | ID: mdl-18401897
9.
Antibody engineering principles and applications.
Cancer J
; 14(3): 149-53, 2008.
Artículo
en Inglés
| MEDLINE | ID: mdl-18536554
10.
Encapsidation of nanoparticles by red clover necrotic mosaic virus.
J Am Chem Soc
; 129(36): 11111-7, 2007 Sep 12.
Artículo
en Inglés
| MEDLINE | ID: mdl-17705477
11.
Cellular uptake of gold nanoparticles passivated with BSA-SV40 large T antigen conjugates.
Anal Chem
; 79(23): 9150-9, 2007 Dec 01.
Artículo
en Inglés
| MEDLINE | ID: mdl-17973401
12.
Controlled encapsidation of gold nanoparticles by a viral protein shell.
J Am Chem Soc
; 128(14): 4502-3, 2006 Apr 12.
Artículo
en Inglés
| MEDLINE | ID: mdl-16594649
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