Head of manufacture
At RISE we know the entire pharmaceutical development chain, from target to patient. We can help with process development, analysis (GMP/GLP), formulation and production (GMP) of the pharmaceutical product for clinical trials, but also early risk evaluation of target and safety evaluation according to GLP.
We work with chemical process development, scaling synthesis and formulation of drugs with sometimes high chemical complexity and challenging physical-chemical properties. Drug development ranges from early discovery to late stage development and marketed products. It includes development, manufacturing and documentation according to quality and regulatory requirements.
The scientific process in drug development (from the identification of the active substance to a finished clinical product) is typically iterative, and our interdisciplinary way of work enables optimal problem solving and a high degree of success.
As an independent partner, we are leading several national collaborative projects aimed at understanding the challenges and proposing solutions for new types of medicines, both at the community level and the technical level. Examples of national and international projects where RISE coordinates or participates include NextBioForm, IMI/ENABLE, CAMP and Swelife-ATMP.