title: [Regulatory consequences for the use of monoclonal antibodies].
abstract: Köhler and Milstein published a method for the manufacture of mouse monoclonal antibodies of predefined specificity 1975 [1], a work rewarded with the Nobel Prize 1984. Since then, the field has developed rapidly with new production methods such as recombinant DNA technology, phage display and genetically engineered animals. Following the first clinical applications with a mouse monoclonal antibody, new classes as chimaeric, humanized and human monoclonal antibodies appeared, with the advantages of less adverse reactions and better efficacy. The development over more than 30 years resulted in more than 25 approved products on the market for various therapeutic applications, e.g. for the treatment of cancer, inflammatory diseases, heart disease and transplantation, and medicines for many more applications are currently under development.
authors.affiliation: AGES Pharmmed, Austrian Agency for Health and Food Safety, OMCL, Possingergasse 38, A-1160 Vienne, France. friedrich.lackner@ages.at
authors.forename: Friedrich
authors.initials: F
authors.lastname: Lackner
authors.forename: Marie-Emmanuelle
authors.initials: ME
authors.lastname: Behr-Gross
mesh_terms: D000818:Animals; D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000145:classification / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized; D002986:Clinical Trials as Topic; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D004353:Drug Evaluation, Preclinical; D004345:Drug Industry / Q000331:legislation & jurisprudence; D005062:European Union; D005544:Forecasting; D006801:Humans; D007390:International Agencies / Q000331:legislation & jurisprudence* / Q000592:standards; D051379:Mice; D011785:Quality Assurance, Health Care; D012306:Risk; D056737:Safety-Based Drug Withdrawals; D013678:Technology, Pharmaceutical / Q000331:legislation & jurisprudence*; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; C509303:TGN-1412