Managing unwanted immunogenicity of biologicals.
All protein drugs (biologicals) have an immunogenic potential and we are armed with multiple guidelines, regulatory documents and white papers to assist us in assessing the level of risk for unwanted immunogenicity of new biologicals. However, for certain biologicals, significant immunogenicity becomes only apparent after their use in patients. Causes of immunogenicity are multifactorial but not yet fully understood. Within the pharmaceutical industry there are only a few opportunities to openly discuss the causes and consequences of immunogenicity with regard to the development of new biologicals. The annual Open Scientific Symposium of the European Immunogenicity Platform (EIP) is one such meeting that brings together scientists and clinicians from academia and industry to build know-how and expertise in the field of immunogenicity. The critical topics discussed at the last EIP meeting (February 2014) will be reviewed here. The current opinion of this expert group is that the assessment of unwanted immunogenicity can be improved by using prediction tools, optimizing the performance of immunogenicity assays and learning from the clinical impact of other biologicals that have already been administered to patients. A multidisciplinary approach is warranted to better understand and minimize drug immunogenicity and its clinical consequences.
Novimmune SA, 14 Chemin des Aulx, 1228 Plan-Les-Ouates, Geneva, Switzerland. Electronic address: mdeehan@novimmune.com.
Maureen
M
Deehan
Gulbenkian Institute of Science, Portugal, Rua da Quinta Grande, 6, 2780-156 Oeiras, Portugal; Garcia de Orta Hospital, Portugal, Department of Rheumatology; HGO Research Center, Av. Torrado da Silva, 2801-951 Almada, Portugal. Electronic address: sandragarcesmail@gmail.com.
Sandra
S
Garcês
Sanofi, R&D, DSAR-PSI, Industriepark Höchst, D-65926 Frankfurt/M., Germany. Electronic address: daniel.kramer@sanofi.com.
Daniel
D
Kramer
Abzena, Babraham Research Campus, Babraham, Cambridge CB22 3AT, United Kingdom. Electronic address: matthew.baker@abzena.com.
Matthew P
MP
Baker
Sanofi, R&D, DSAR-BBB, Industriepark Höchst, D-65926 Frankfurt/M., Germany. Electronic address: dorothea.rat@sanofi.com.
Dorothea
D
Rat
Sanofi, R&D, DSAR-BBB, Industriepark Höchst, D-65926 Frankfurt/M., Germany. Electronic address: yvonne.roettger@sanofi.com.
Yvonne
Y
Roettger
Institute for Immunology, University of Kiel, Germany, Arnold-Heller-Straße 3, Haus 17, 24105 Kiel, Germany; IPM Biotech, Lademannbogen 61, 22453 Hamburg, Germany. Electronic address: arno.kromminga@ipm-biotech.de.
Arno
A
Kromminga
D000906:Antibodies / Q000276:immunology*; D000917:Antibody Formation; D055808:Drug Discovery; D004342:Drug Hypersensitivity; D006801:Humans; D055261:Immunogenetic Phenomena; D023421:Models, Animal
D000906:Antibodies
Adalimumab; Anti-drug antibodies; Biological drugs; Etanercept; Immunogenicity; Infliximab; Therapeutic drug monitoring