Immunogenicity Risk Assessment for an Engineered Human Cytokine Analogue Expressed in Different Cell Substrates

Author:

Chamberlain PaulORCID,Rup Bonita

Publisher

Springer Science and Business Media LLC

Subject

Pharmaceutical Science

Reference65 articles.

1. Food and Drug Administration. Guidance for industry—immunogenicity assessment for therapeutic protein products, FDA, CDER/CBER; 2014.

2. European Medicines Agency. Guideline on immunogenicity assessment of therapeutic proteins (EMEA/CHMP/BMWP/14327/2006 Rev 1). Committee for Medicinal Products for Human Use (CHMP); 2017. Retrieved from http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2017/06/WC500228861.pdf. Accessed 12 Oct 2019.

3. Tangri S, Mothé BR, Eisenbraun J, Sidney J, Southwood S, Briggs K, et al. Rationally engineered therapeutic proteins with reduced immunogenicity. J Immunol. 2005;174(6):3187–96. https://doi.org/10.4049/jimmunol.174.6.3187.

4. De Groot AS, Scott DW. Immunogenicity of protein therapeutics. Trends Immunol. 2007;28(11):482–90. https://doi.org/10.1016/j.it.2007.07.011.

5. Weber CA, Mehta PJ, Ardito M, Moise L, Martin B, De Groot AS. T cell epitope: friend or foe? Immunogenicity of biologics in context. Adv Drug Deliv Rev. 2009;61(11):965–76. https://doi.org/10.1016/j.addr.2009.07.001.

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