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PERTH, Australia, March 17, 2026 /PRNewswire/ — BioCina Pty Ltd., a global end-to-end Contract Development and Manufacturing Organisation (CDMO) announced it has initiated a comprehensive CMC (Chemistry, Manufacturing, and Controls) program for the advancement of RLS-2201, a proprietary injectable formulation of Quetiapine being developed by Patrys Ltd (ASX: PAB) for the acute treatment of delirium in intensive care settings.
Sterile injectable manufacturing using a closed isolator system, BioCina Perth
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 Patrys’ planned first-in-human clinical activities.
“We are proud to be advancing RLS-2201 alongside a world-class CDMO partner whose deep manufacturing expertise and technical capabilities are proving instrumental in de-risking this program. Their collaborative approach to regulatory engagement gives us strong confidence as we move toward clinical trials. Together, we believe RLS-2201 has the potential to address a critical unmet need in the treatment of delirium in acute hospital settings,” said Dr. Samantha South, CEO, Patrys.
The initiation of CMC activities represents a significant de-risking step for the RLS-2201 program. 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.
“We are thrilled to support Patrys’ journey for RLS-2201. BioCina’s 50 years of experience in the development and manufacturing of sterile injectables is more than just a capability. We ensure partners like Patrys can progress to clinic with confidence, and keep the focus where it belongs – improving patient outcomes,” said Dr. Tommy Broudy, CEO, BioCina.
About BioCina
BioCina is a global end-to-end Contract Development and Manufacturing Organisation (CDMO) with over 50 years of sterile Drug Product manufacturing experience, serving clients across the U.S., Europe, and Asia Pacific. With facilities recognised by the US FDA, EMA, TGA, and other key regulatory authorities, BioCina delivers Drug Substance and Drug Product solutions from early development through to commercial scale.
BioCina’s capabilities span sterile injectable manufacturing of small and large molecule products in multiple formats, as well as microbial biologics, pDNA, mRNA and LNP-based modalities. Partnering with BioCina in Australia provides clients with access to one of the world’s most attractive R&D tax incentive programs, offering a meaningful cost advantage throughout development and manufacture.
For more information, visit www.biocina.com
About Patrys
Based in Perth, Australia, Patrys, (ASX: PAB), is a clinical-stage biotechnology company advancing a dual-platform strategy combining innovative antibody therapeutics with a near-term CNS pharmaceutical program. Patrys’ deoxymab platform comprises novel cell-penetrating antibodies targeting intracellular disease mechanisms with a focus on immune-mediated inflammatory and other high-unmet-need indications.
Patrys’ CNS program, RLS-2201, is a proprietary injectable reformulation of quetiapine for the treatment of delirium in intensive, aged and palliative care setting, advancing via the FDA 505(b)(2) regulatory pathway. Together, these platforms position Patrys as a catalyst-rich, balanced development company, combining a de-risked reformulation asset with longer-term biologics innovation.
For more information, visit www.patrys.com
Media Contact
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