… There have been several excellent reviews on this subject, … glycan structures on
biopharmaceutical products is especially … been made to standardize nomenclature and …

… interpretation of the product's immunogenicity and its clinical effects. Efforts are ongoing to
standardize … Broadly, both the EMA and FDA guidelines are aligned and well-harmonized with …

… the European Immunogenicity Platform (EIP) reviews currently … and next steps toward
harmonization and standardization. … interpretation and translation into an overall immunogenicity …

… current guidance recommendations for immunogenicity content … by standardizing
immunogenicity-related terminology and … Future work understanding past evaluation practices and …

… application for novel biopharmaceutical products in ICH … other regulatory guidelines provide
recommendations for … population can preclude a full understanding of the nature of the risks …

… However, there is no common understanding in which cases … In recent years, concepts for
the initial risk assessment have … is recommended in case of high risk of immunogenicity) until …

… from the Innovative Medicines Initiative Joint Undertaking under … recommendations used by
the pharmaceutical industry [6]. … encoded to standardized terms with the MedDRA dictionary, …

… Regulatory agencies have issued specific guidelines to therapeutic protein immunogenicity
… the terms and definitions for data interpretation in the field of unwanted immunogenicity was …

… initiatives and is attempting to strengthen the understanding of … in some cases they even
suggest ideas to be considered for … 10 consortium has produced a set of recommendations for …

… , standardized and uploaded into the ABIRISK (Anti-Biopharmaceutical Immunization: …
P Dönnes reports grants from Innovative Medicines Initiative Joint Undertaking during the …