13/14 December 2022
In autumn 2015, the EMA published the "Draft guideline on immunogenicity assessment of biotechnology-derived therapeutic proteins" This document is supposed to replace the "Guideline on immunogenicity assessment of biotechnology-derived therapeutic proteins from 2006.
The increasing number of biological/biotechnology-derived proteins used as therapeutic agents and the experiences from marketing authorisation applications on unwanted immune responses as well as other new information necessitated an update of the requirements for assays for immunogenicity and integrated analysis of the clinical significance of immunogenicity.
The new draft includes information about:
The EMA defines the scope of that draft as follows:
"The general principles adopted and explained in this document mainly apply to the development of an unwanted immune response against a therapeutic protein in patients and to a systematic evaluation of it. The guideline applies to proteins and polypeptides, their derivatives, and products of which they are components, e.g. conjugates. These proteins and polypeptides are mainly produced by recombinant or non-recombinant expression systems. Throughout this guideline, the term “therapeutic protein” is used."
More details can be found in the "Guideline on Immunogenicity assessment of biotechnology-derived therapeutic proteins" which is open for comments until 31 January 2016.