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1.
Multicenter assessment and longitudinal study of the prevalence of antibodies and related adaptive immune responses to AAV in adult males with hemophilia.
Gene Ther
; 31(5-6): 273-284, 2024 05.
Artículo
en Inglés
| MEDLINE | ID: mdl-38355967
2.
Whole Body and CNS Biodistribution of rhHNS in Cynomolgus Monkeys after Intrathecal Lumbar Administration: Treatment Implications for Patients with MPS IIIA.
Int J Mol Sci
; 18(12)2017 Dec 01.
Artículo
en Inglés
| MEDLINE | ID: mdl-29194406
3.
A phase I/II study of intrathecal idursulfase-IT in children with severe mucopolysaccharidosis II.
Genet Med
; 18(1): 73-81, 2016 Jan.
Artículo
en Inglés
| MEDLINE | ID: mdl-25834948
4.
A phase 1/2 study of intrathecal heparan-N-sulfatase in patients with mucopolysaccharidosis IIIA.
Mol Genet Metab
; 118(3): 198-205, 2016 07.
Artículo
en Inglés
| MEDLINE | ID: mdl-27211612
5.
Online 2D-LC-MS/MS assay to quantify therapeutic protein in human serum in the presence of pre-existing antidrug antibodies.
Anal Chem
; 87(16): 8555-63, 2015 Aug 18.
Artículo
en Inglés
| MEDLINE | ID: mdl-26237058
6.
Immunogenicity profile of rurioctocog alfa pegol in previously treated patients with severe congenital hemophilia A.
Blood Adv
; 8(11): 2726-2739, 2024 Jun 11.
Artículo
en Inglés
| MEDLINE | ID: mdl-38564770
7.
The Fe and Zn cofactor dilemma.
Biochim Biophys Acta Proteins Proteom
; 1871(5): 140931, 2023 09 01.
Artículo
en Inglés
| MEDLINE | ID: mdl-37353133
8.
2022 White Paper on Recent Issues in Bioanalysis: FDA Draft Guidance on Immunogenicity Information in Prescription Drug Labeling, LNP & Viral Vectors Therapeutics/Vaccines Immunogenicity, Prolongation Effect, ADA Affinity,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
9.
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
10.
Anti-drug Antibody Sample Testing and Reporting Harmonization.
AAPS J
; 24(6): 113, 2022 10 28.
Artículo
en Inglés
| MEDLINE | ID: mdl-36307592
11.
A Rapid Two-Step Iduronate-2-Sulfatatse Enzymatic Activity Assay for MPSII Pharmacokinetic Assessment.
JIMD Rep
; 38: 89-95, 2018.
Artículo
en Inglés
| MEDLINE | ID: mdl-28643276
12.
A novel LC-MS/MS assay to quantify dermatan sulfate in cerebrospinal fluid as a biomarker for mucopolysaccharidosis II.
Bioanalysis
; 10(11): 825-838, 2018 Jun 01.
Artículo
en Inglés
| MEDLINE | ID: mdl-29863901
13.
Generation of assay positive controls for detection of isotype anti-drug antibodies for immunogenicity monitoring.
Bioanalysis
; 9(20): 1603-1615, 2017 Oct.
Artículo
en Inglés
| MEDLINE | ID: mdl-29072493
14.
A comparison study of bioanalytical methods for characterization of anti-idursulfase antibodies.
Bioanalysis
; 9(16): 1237-1246, 2017 Aug.
Artículo
en Inglés
| MEDLINE | ID: mdl-28766362
15.
A biotin-drug extraction and acid dissociation (BEAD) procedure to eliminate matrix and drug interference in a protein complex anti-drug antibody (ADA) isotype specific assay.
J Immunol Methods
; 446: 30-36, 2017 07.
Artículo
en Inglés
| MEDLINE | ID: mdl-28389174
16.
Levels of glycosaminoglycans in the cerebrospinal fluid of healthy young adults, surrogate-normal children, and Hunter syndrome patients with and without cognitive impairment.
Mol Genet Metab Rep
; 5: 103-106, 2015 Dec.
Artículo
en Inglés
| MEDLINE | ID: mdl-28649553
17.
Sulfatide levels correlate with severity of neuropathy in metachromatic leukodystrophy.
Ann Clin Transl Neurol
; 2(5): 518-33, 2015 May.
Artículo
en Inglés
| MEDLINE | ID: mdl-26000324
18.
A novel monoclonal antibody inhibits the immune response of human cells against porcine cells: identification of a porcine antigen homologous to CD58.
Transplantation
; 77(8): 1288-94, 2004 Apr 27.
Artículo
en Inglés
| MEDLINE | ID: mdl-15114100
19.
Development of a panel of highly sensitive, equivalent assays for detection of antibody responses to velaglucerase alfa or imiglucerase enzyme replacement therapy in patients with Gaucher disease.
J Immunol Methods
; 373(1-2): 45-53, 2011 Oct 28.
Artículo
en Inglés
| MEDLINE | ID: mdl-21846471
20.
A Cerebrospinal Fluid Collection Study in Pediatric and Adult Patients With Hunter Syndrome
J. inborn errors metab. screen
; 3: e150002, 2015. tab, graf
Artículo
en Inglés
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LILACS-Express
| ID: biblio-1090864