title: How to systematically evaluate immunogenicity of therapeutic proteins - regulatory considerations.
abstract: Antibody formation as an immune reaction to a 'foreign' protein antigen is an expected physiological reaction that is in many cases intentionally triggered, for example in the case of vaccinations. However, an unwanted immune response to a therapeutic protein may lead to a loss of efficacy and/or to severe side effects. The Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMEA) issued a multidisciplinary guideline providing general recommendations from a marketing authorisation perspective on how to assess an unwanted immune response following the administration of a biological drug. In this article, we provide an in-depth regulatory discussion on key principles of systematic evaluation of immunogenicity during development of biotechnological medicinal products, including examples.
authors.affiliation: Paul-Ehrlich-Institut, Division EU Cooperation/Microbiology, Langen, Germany. schci@pei.de <schci@pei.de>
authors.forename: Eva-Maria
authors.initials: EM
authors.lastname: Jahn
authors.forename: Christian K
authors.initials: CK
authors.lastname: Schneider
mesh_terms: D001688:Biological Products / Q000008:administration & dosage* / Q000032:analysis / Q000276:immunology; D001709:Biotechnology; D017277:Drug Approval / Q000458:organization & administration*; D004345:Drug Industry; D064420:Drug-Related Side Effects and Adverse Reactions; D017408:Guidelines as Topic; D006801:Humans; D007109:Immunity; D007880:Legislation, Drug; D040541:Marketing; D011506:Proteins / Q000276:immunology* / Q000627:therapeutic use*; D012307:Risk Factors
chemical_list: D001688:Biological Products; D011506:Proteins