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Recommendations for the Development and Validation of Immunogenicity Assays in Support of Biosimilar Programs.

Autor: Civoli F; Coherus BioSciences, Redwood City, CA, USA. fcivoli@coherus.com., Kasinath A; Syngene International Ltd, Bangalore, India., Cai XY; Accurant Biotech, Inc., Cranbury, New Jersey, USA., Wadhwa M; Medicines and Healthcare Products Regulatory Agency (MHRA), National Institute for Biological Standards and Control (NIBSC), Hertfordshire, UK., Exley A; Regulatory Division, Medicines and Healthcare Products Regulatory Agency (MHRA), London, UK., Oldfield P; Philip Oldfield Bioanalytical Consulting, Quebec, Canada., Alvandkouhi S; BioAgilytix Labs, Durham, North Carolina, USA., Schaffar G; Hexal AG , Oberhaching, Germany., Chappell J; Gyros Protein Technologies, Uppsala, Sweden., Bowsher R; B2S Life Sciences, Franklin, Indiana, USA., Devanarayan V; GlaxoSmithKline, Collegeville, Pennsylvania, USA., Marini J; Janssen Research & Development, LLC, Spring House, Pennsylvania, USA., Rebarchak S; Janssen Research & Development, LLC, Spring House, Pennsylvania, USA., Anderson M; Immunologix Laboratories, Tampa, Florida, USA., Koppenburg V; Hexal AG, Holzkirchen, Germany., Lester T; BioAgilytix Labs, Durham, North Carolina, USA.

Publikováno v: The AAPS journal [AAPS J] 2019 Dec 02; Vol. 22 (1), pp. 7. Date of Electronic Publication: 2019 Dec 02.