Purchase of Formulation development and GMP manufacture of tablets for early clinical development

DTU intends to purchase Formulation development and GMP manufacture of tablets for early clinical development from Porton Pharmaceutical Chemicals GmbH. The acquisition concerns specialized pharmaceutical development and manufacturing services required to enable a first-in-human clinical study within the Microbiome Health Initiative (MHI). The services include formulation development, analytical method development and validation, non-GMP and GMP manufacture of an oral solid dosage form (tablets), stability studies, and preparation of documentation to support regulatory submissions (IND/IMPD). The work covers the full IND-enabling drug product package for a novel small-molecule compound within the bile acid class, intended for use in a Phase I human intervention study. The services are highly specialized, research- and development-driven, and closely linked to the specific and regulatory requirements of the project.