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1.
Two-center validation of assays for the detection of binding and neutralizing anti-factor VIII antibodies.
Haemophilia
; 30(1): 224-231, 2024 Jan.
Artículo
en Inglés
| MEDLINE | ID: mdl-37824540
2.
Pegunigalsidase alfa, a novel PEGylated enzyme replacement therapy for Fabry disease, provides sustained plasma concentrations and favorable pharmacodynamics: A 1-year Phase 1/2 clinical trial.
J Inherit Metab Dis
; 42(3): 534-544, 2019 05.
Artículo
en Inglés
| MEDLINE | ID: mdl-30834538
3.
Therapeutic outcomes, assessments, risk factors and mitigation efforts of immunogenicity of therapeutic protein products.
Cell Immunol
; 295(2): 118-26, 2015 Jun.
Artículo
en Inglés
| MEDLINE | ID: mdl-25880103
4.
Preclinical models used for immunogenicity prediction of therapeutic proteins.
Pharm Res
; 30(7): 1719-28, 2013 Jul.
Artículo
en Inglés
| MEDLINE | ID: mdl-23649852
5.
Survey Outcome on Immunogenicity Risk Assessment Tools for Biotherapeutics: an Insight into Consensus on Methods, Application, and Utility in Drug Development.
AAPS J
; 25(4): 55, 2023 06 02.
Artículo
en Inglés
| MEDLINE | ID: mdl-37266912
6.
Coupling of aggregation and immunogenicity in biotherapeutics: T- and B-cell immune epitopes may contain aggregation-prone regions.
Pharm Res
; 28(5): 949-61, 2011 May.
Artículo
en Inglés
| MEDLINE | ID: mdl-21437790
7.
Immunogenicity Risk Assessment for an Engineered Human Cytokine Analogue Expressed in Different Cell Substrates.
AAPS J
; 22(3): 65, 2020 04 14.
Artículo
en Inglés
| MEDLINE | ID: mdl-32291556
8.
Immunogenicity of biologically-derived therapeutics: assessment and interpretation of nonclinical safety studies.
Regul Toxicol Pharmacol
; 54(2): 164-82, 2009 Jul.
Artículo
en Inglés
| MEDLINE | ID: mdl-19345250
9.
Recommendations on risk-based strategies for detection and characterization of antibodies against biotechnology products.
J Immunol Methods
; 333(1-2): 1-9, 2008 Apr 20.
Artículo
en Inglés
| MEDLINE | ID: mdl-18275969
10.
Recommendations for the design, optimization, and qualification of cell-based assays used for the detection of neutralizing antibody responses elicited to biological therapeutics.
J Immunol Methods
; 321(1-2): 1-18, 2007 Apr 10.
Artículo
en Inglés
| MEDLINE | ID: mdl-17307199
11.
Immunogenicity of glycans on biotherapeutic drugs produced in plant expression systems-The taliglucerase alfa story.
PLoS One
; 12(10): e0186211, 2017.
Artículo
en Inglés
| MEDLINE | ID: mdl-29088235
12.
Evaluation of pre-existing antibody presence as a risk factor for posttreatment anti-drug antibody induction: analysis of human clinical study data for multiple biotherapeutics.
AAPS J
; 15(3): 893-6, 2013 Jul.
Artículo
en Inglés
| MEDLINE | ID: mdl-23761225
13.
Relationship between potential aggregation-prone regions and HLA-DR-binding T-cell immune epitopes: implications for rational design of novel and follow-on therapeutic antibodies.
J Pharm Sci
; 101(8): 2686-701, 2012 Aug.
Artículo
en Inglés
| MEDLINE | ID: mdl-22619033
14.
Recommendations for the validation of cell-based assays used for the detection of neutralizing antibody immune responses elicited against biological therapeutics.
J Pharm Biomed Anal
; 55(5): 878-88, 2011 Jul 15.
Artículo
en Inglés
| MEDLINE | ID: mdl-21531522
15.
Critical ligand binding reagent preparation/selection: when specificity depends on reagents.
AAPS J
; 9(2): E148-55, 2007 May 11.
Artículo
en Inglés
| MEDLINE | ID: mdl-17614357
16.
Reduced bleeding events with subcutaneous administration of recombinant human factor IX in immune-tolerant hemophilia B dogs.
Blood
; 102(13): 4393-8, 2003 Dec 15.
Artículo
en Inglés
| MEDLINE | ID: mdl-12933577
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