BioCina Pty Ltd, a global Contract Development and Manufacturing Organisation (CDMO), has launched a comprehensive manufacturing program for RLS-2201, a proprietary injectable formulation of Quetiapine being developed by Patrys Ltd (ASX: PAB) for the acute treatment of delirium in intensive care.
The program is being executed at BioCina’s sterile manufacturing facility in Perth.
According to a statement from BioCina, the reformulated RLS-2201 is being produced under conditions designed to confirm the reproducibility and robustness of the manufacturing process.
The program will also support ICH-aligned stability studies required for regulatory submission and provide early supply for Patrys’ planned first-in-human clinical trials.
“We are thrilled to support Patrys’ journey for RLS-2201,” said Dr. Tommy Broudy, CEO of BioCina. “BioCina’s 50 years of experience in the development and manufacturing of sterile injectables ensures partners like Patrys can progress to clinic with confidence and keep the focus where it belongs — improving patient outcomes.”
Patrys CEO Dr Samantha South added that the collaboration benefits from BioCina’s technical capabilities and regulatory expertise. “We are proud to be advancing RLS-2201 alongside a world-class CDMO partner whose deep manufacturing expertise is proving instrumental in de-risking this program,” she said.
“Together, we believe RLS-2201 has the potential to address a critical unmet need in the treatment of delirium in acute hospital settings.”
BioCina noted that initiating the CMC (Chemistry, Manufacturing, and Controls) program represents a key de-risking step, validating the manufacturing process and creating a regulatorily defensible pathway toward clinical trial entry, targeted for the second half of 2026.
The content of this article is based on information supplied by BioCina Pty Ltd and Patrys Ltd. For more information, please refer to the official company announcement and communications from the companies. Please consult a licensed and/or registered professional in this area before making any decisions based on the content of this article.
