Validation of an Immunoassay for Anti-thymidine Phosphorylase Antibodies in Patients with MNGIE Treated with Enzyme Replacement Therapy

Author:

Levene Michelle,Pacitti Dario,Gasson Charlotte,Hall Jamie,Sellos-Moura Marcia,Bax Bridget E.

Funder

Medical Research Council

Publisher

Elsevier BV

Subject

Genetics,Molecular Biology,Molecular Medicine

Reference29 articles.

1. Enzymes approved for human therapy: indications, mechanisms and adverse effects;Baldo;BioDrugs,2015

2. Immune response to enzyme replacement therapies in lysosomal storage diseases and the role of immune tolerance induction;Kishnani;Mol. Genet. Metab.,2016

3. U.S. Food and Drug Administration. (2014). Guidance for industry: immunogenicity assessment for therapeutic protein products. Report of the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), and Center for Biologics Evaluation and Research (CBER). August 2014. https://www.fda.gov/downloads/drugs/guidances/ucm338856.pdf.

4. European Medicines Agency. (2017). Guideline on immunogenicity assessment of therapeutic proteins. May 18, 2017. EMEA/CHMP/BMWP/14327/2006 Rev 1. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2017/06/WC500228861.pdf.

5. International seminar on the red blood cells as vehicles for drugs;Godfrin;Expert Opin. Biol. Ther.,2012

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