This biotechnologically produced drug is a passive vaccine in the form of a complete human antibody that binds to the spike protein on the viral envelope of SARS-CoV-2. This should prevent the virus from spreading the infection in the body. In contrast to a broad range of active vaccines that are currently being developed to protect healthy individuals from contracting the disease, the new antibody can help patients who already have COVID-19.
The Fraunhofer researchers in Braunschweig have designed a completely new strategy for this purpose, which shortens the process development time for the production of investigational medicinal products for clinical trials down to a few months – in contrast to the usual 1.5 to 2 years. The competent authority has already agreed to this novel, significantly accelerated development strategy.
Fraunhofer ITEM was significantly supported in this process by experts from Bayer AG. "The aim of this treatment is to stop the infection early in its tracks, so that the typical severe clinical symptoms of the disease don’t get a chance to develop. Preventive administration to health-care workers and high-risk patients as a passive vaccine for immediate protection is also conceivable," says Professor Stefan Dübel, one of the initiators of the project at the Institute of Biotechnology at Technische Universität Braunschweig. "Antibodies are the fastest-growing class of modern drugs. The project has identified possibilities for alternative production and development strategies that might enable not only the active substance against COVID-19 but also other future biopharmaceutical candidates to enter clinical trials more quickly and hence more cost-effectively," adds Professor Holger Ziehr, head of Pharmaceutical Biotechnology at Fraunhofer ITEM.