For a Phase 1 study with CMC on the critical path for a challenging compound, we worked with Nanopharm to design a Dry Powder Inhaler (DPI) capsule formulation, manufacturing process and analytical methodology. Nanopharm then transferred these to a Contract Manufacturing Organisation (CMO), with GMP manufacturing capabilities, who manufactured the clinical batches.
In a true Quality by Design manner, we started with characterisation of the API and excipient interfacial properties and, putting this together with fundamental knowledge of various excipient grades, Nanopharm succeeded in making a formulation and process that was robust, both for the broad dosing strength range and environmental manufacturing conditions, and that was also stable.
The interaction with Nanopharm was both data and science driven, which was an optimum combination to deliver the most robust formulation by design. Three months after project kickoff, Nanopharm started the transfer to the CMO, implemented Next Generation Impactor and Delivered Dose methods at the CMO, and trained and helped the operators and analysts in the manufacturing and testing of the DPI product. The first patient was dosed 9 months after Nanopharm started the first work. The robustness of the formulation was confirmed by the GMP batches. Lessons learned were defined to further shorten timelines and yet reach same robust quality.
F. Vanhoutte – Scientific Director at Janssen R&D