The collaboration of MIT BioMAN, GWDG as well as the industrial partner Sartorius aims to improve the knowledge of certain chemical compounds, the so-called Extractables & Leachables (E&L). In the manufacturing process of drugs and products, components and substances form a complex interrelationship. A comprehensive risk assessment and process qualification for E&L substances are required to ensure product safety and meet regulatory requirements. The collaborating partners are trying to create a shared data source that simplifies access to E&L information and provides standards for the biopharmaceutical industry.
GWDG is supporting the development of an information-driven architecture to access information on E&L substances and the scientific facets. This includes schemas for aggregation and scientific analysis of the data.