Dr. Barbara Mayer, SpheroTec GmbH, Martinsried/Munich, Germany
Biologicals are therapeutics developed by a biological process, which is contrary to chemically synthesized drugs. Biologicals are isolated from genetically modified microbial cells, mammalian cell lines and plant cell cultures. The first biological on the market was human insulin in 1982 made via recombinant DNA technology. Since then the number of biological approved dramatically increased having a deep impact in various medical fields, especially in metabolism, rheumatology, neurology and oncology. Major kinds of biological include blood factors, thrombolytic agents, hormones, haematopoetic growth factors, vaccines and monoclonal antibodies. Development, production and commercialization of biologicals are time consuming, costly and strongly regulated.
Often, in parallel to the biological the corresponding biomarker test is developed. This companion diagnostic aims to stratify patients in responders and non-responders resulting in an increased success rate of treatment. However,” omics” technologies lead to a continuously better understanding of the drugable biomarkers resulting in patient subgroups and personalized therapy. This requires innovative diagnostic tests to identify the right biological for the right patient in the right dose.
