Manufacturing

Manufacturing enables distinguishing between raw material, the drug substance or active pharmaceutical ingredient (API) and the candidate medicinal product.

During the research and discovery phase, only small amounts of the drug substance or API are produced. However, for further development to non-clinical studies, production of the drug substance should be increased and for clinical studies this should be manufactured according to good manufacturing practice (GMP). After production of the drug substance it should be further formulated to a candidate medicinal product, a drug product. This could, for instance, be a tablet or a powder that is dissolved for infusion.

Academic pharma works together with other companies to upscale the manufacturing process and make it GMP. The main focus of Manufacturing in Academic Pharma is on innovations, especially for personalized treatment. Within Academic Pharma, there are projects in which the candidate medicinal product is manufactured on a small scale or formulated on larger scale.