Anti-Biopharmaceutical Immunization: prediction
and analysis of clinical relevance to minimize the RISK
Many terms and definitions pertaining to immunogenicity, in particular those used for reporting anti-drug antibodies results, have been in common use throughout the medical and scientific and pharmaceutical communities. However, various disease areas and scientific disciplines have used different terms or have defined the same terms in different ways.
One of the first goals of the ABIRISK consortium was to provide clear definitions around terms and concepts related to immunogenicity, its prediction and associated clinical events.
Beyond the reporting of anti-drug antibodies data, ABIRISK will also be reporting data on cellular and pharmacogenomic markers of immunogenicity and results from predictive immunogenicity methods.
Agreement on terms and definitions to describe and implement these new and emerging aspects of immunogenicity science will also be an outcome of the ABIRISK goals.
The document "Proposed terms and definitions for reporting immunogenicity results" has been recently finalized by ABIRISK consortium members and it have been just published on Clinical & Experimental Immunology.
"Proposed terms and definitions for reporting immunogenicity results" will be presented and distributed to key international organizations (e.g. european Immunogenicity Platform-eIP, AAPS Therapeutic Protein Immunogenicity focus group, ligand Binding Assay Bioanalytical focus groups etc.) asking for their comments and suggestions to further improve it.
Please, download the document and write your feedback. All your comments and suggestions will be taken into consideration and well appreciated! Thanks in advance for your kind collaboration!!!
|Proposed terms and definitions for reporting immunogenicity results|