Australia-based startup BioCina, a global end-to-end Contract Development and Manufacturing Organisation (CDMO), has initiated a comprehensive CMC (Chemistry, Manufacturing, and Controls) programme for the advancement of RLS-2201, a proprietary injectable formulation of Quetiapine being developed by Patrys for the acute treatment of delirium in intensive care settings.
A reformulated RLS-2201 is being produced at BioCina's sterile manufacturing facility in Perth, under conditions designed to confirm the reproducibility and robustness of the manufacturing process. The reformulated RLS-2201 will support ICH-aligned stability studies required for regulatory submission and provide early supply for Australia-based Patrys' planned first-in-human clinical activities.
By validating the manufacturing process for clinical readiness at this stage, Patrys and BioCina are establishing a technically sound and regulatorily defensible pathway toward clinical trial entry, targeted for the second half of 2026. This engagement further strengthens BioCina's partnership with Patrys, reflecting BioCina's commitment to supporting clients at every stage of their product development journey.
