Characterization and Recovery of Bionanoparticles for Vaccine Delivery and Gene Therapy

ongoing

The Doctoral Network CAARE - “Characterization and Recovery of Bionanoparticles for Vaccine Delivery and Gene Therapy” focuses on a rapidly emerging field in biopharmaceutical industry and a new class of molecules, the bionanoparticles. Bionanoparticles are currently used as conventional vaccines, mRNA vaccines or gene therapy. These new biopharmaceuticals will satisfy an urgent medical need as they might extend the curability of to-date non-curable diseases and offer treatment for rare diseases. However, the impact of the manufacturing process for such therapies on the final product quality and consequently on product efficacy and patient safety is still not fully understood. There also is a lack of specifically trained personnel in the field of bionanoparticles. In CAARE we will develop new and intensified downstream processes and analytical tools, which are essential to obtain a pure therapeutic product and to ensure the efficacy and safety of the therapy. acib GmbH (AT), Karlsruhe Institute of Technology, University of Hamburg and University of Erlangen (all DE), Institute of Experimental Biology and Technology (PT), Leiden University Medical Centre (NL), and Icosagen (EE), seven associated industry partners, two associated universities and one regulatory agency have formed a consortium to train 14 doctoral candidates with beyond state-of-the art bioprocess and analytical skills directed for bionanoparticle purification. Latest technology of process control and monitoring for advanced bionanoparticle processing, downstream process development and particle characterization of bionanoparticles will be taught. The appropriate skills to communicate the research outcome to the scientific community and to the general public are included in the training program. We will establish a new training creating a generation of scientists that can contribute to the establishment of technologies/methodologies in a rapidly emerging field in biopharmaceutical manufacturing.