MIT BioMAN

The collaboration among MIT BioMAN, GWDG as well as the industrial partner Sartorius aims to deepen the understanding of certain chemical compounds – the so-called Extractables & Leachables (E&L). In biomanufacturing, components and substances form a complex interrelationship that significantly affects the production of pharmaceuticals and other products. To ensure product safety and meet regulatory requirements, a comprehensive risk assessment and process qualification for E&L substances are essential. The collaborating partners are developing a shared data source that not only simplifies access to E&L information but also sets new standards for the biopharmaceutical industry.

GWDG is supporting the creation of an information-driven architecture to facilitate access to E&L data as well as their scientific facets. This also includes schemas for aggregating and scientifically analyzing the data in order to gain fundamental insights into E&L compounds.