Immunogenicity, the antibody respons against therapeutic proteins, is of critical importance both during the development of monoclonal therapeutics in phase 2, 3 and 4 trials as well as the therapeutic drug monitoring thereof in daily practice. EMEA and FDA in 2008 issued specific immunogenicity guidelines, for in depth information see below.


In April 2008, the EMEA has adopted a new guidance on immunogenicity assessment of Biologicals.
See CHMP/BMWP/14327/06 (pdf).
See Scientific Guidelines for Human Medicinal Products.  

'EMEA guidance on immunogenicity for biologicals'
Dr Robin Thorpe (pdf)
Head Biotherapeutics Group National Institute for Biological Standards and Control, UK (member of EMEA drafting group)


The FDA has also implemented guidances for immunogenicity testing of Biologicals, see e.g.

'An FDA regulatory perspective on immunogenicity'
Dr Susan Krishner (pdf)
Lab of Immunology, Office of Therapeutic Proteins, FDA, USA

Last edited on: 21 November 2012