Draft guideline on immunogenicity assessment of biotechnology-derived therapeutic proteins

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Download document Draft guideline on immunogenicity assessment of biotechnology-derived therapeutic proteins
Reference number EMEA/CHMP/BMWP/14327/2006 Rev. 1
Status draft: consultation closed
First published 2015-10-01
Last updated 2015-10-01

Summary

The number of biological/biotechnology-derived proteins used as therapeutic agents is steadily increasing. These products may induce unwanted immune responses, which can be influenced by various factors, including patient- and disease-related factors as well as product-related factors.