Drug development
New drugs enable the treatment of diseases that previously had no cure, but development is complex and risky. It takes an average of twelve years, and only one in 5,000 substances is approved. Biological drugs such as vaccines, antibodies, and cell and gene therapies require specialized knowledge of stability, formulation, and immune responses, where the production process itself is an essential part of the final product. Small and medium-sized companies often lack internal expertise across the entire value chain and need external expertise in everything from pharmacology and formulation to regulatory requirements and upscaling. At the same time, the climate crisis and new regulations are driving the need for green transition in a highly regulated industry where life-saving innovations must be balanced against sustainability requirements.
RISE supports drug development from idea to clinical trial by acting as an external R&D unit when companies lack capacity or expertise. Our GMP laboratories produce materials for clinical studies, and through GLP accreditation, we perform preclinical safety studies and toxicological analyses. We develop formulations that ensure stability during storage and transport, analyze immune responses and biological function, and support regulatory documentation and dialogue with authorities. Through NextBioForm, a collaboration center with 18 partners, platforms are created where methods and techniques are verified. RISE also helps companies navigate public funding and develop sustainable production processes according to green chemistry principles.