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Created and Narrated by Maria-Dolores Vazquez-Abad
Recommended References:
Immune response series by Maria-Dolores Vazquez-Abad, (2018 KZfaq)
Basic Immunology. 5th ed. 2015
European Respiratory Journal 2010 36: 1185 DOI: 10.1183/09031936.00028510;
Cellular and Molecular Immunology, 7th edition.
Front Immunol. 2014; 5: 520. doi: 10.3389/fimmu.2014.00520
Immunology Unit 1 Review and Project
J. Immunol. Methods 289, 1-16. (2004)
J. Pharm. Biomed. Anal. 48 (5), 1267-1281. (2008)
EMEA guidelines on Immunogenicity Assessment of Biotechnology-Derived Therapeutic Proteins. www.emea.europa.eu/pdfs/human/...
FDA Guidance for Industry, Assay Development for Immunogenicity Te sting for Therapeutic Proteins. www.fda.gov/downloads/Drugs/Gu...
Clin Chem. 51, 1983-1985. (2005)
ASSAY and Drug Development Technologies. 5(5): 655-662. (2007).
Bioanalysis 2 (4), 721-731(2010)
Boris Gorovits: Bioanalytical Assays for Biotherapeutics 2017 ADME workshop;
Fisher , T.S. et al.Cancer Immunology and Immunotherapy (2012) 61:1721-33
FDA Immunogenicity Assessment for Therapeutic Protein Products
www.fda.gov/Drugs/GuidanceComp...
EMA: Guideline on Immunogenicity assessment of therapeutic proteins 18 May 2017 EMEA/CHMP/BMWP/14327/2006 Rev 1
Glodsy et al Immunology 5th edition, 2003
J Allergy Clin Immunol 2005;115:584-91.