Cartherics has opened a new cleanroom facility in Notting Hill, Victoria, to support the clinical-scale manufacturing of its cell therapy products.
The announcement was made during a launch event attended by stakeholders and industry partners, with the facility officially opened by Federal Member for Chifley, the Hon Ed Husic MP.
The Melbourne-based biotechnology company, which is focused on developing off-the-shelf immune stem cell therapies for high-impact women’s diseases, said the facility will enable the manufacture of clinical batches of its lead cell therapy candidate, CTH-401.
The product is initially being developed for the treatment of relapsed and refractory ovarian cancer, with an investigational new drug (IND) submission to the US Food and Drug Administration expected by mid-2026.
Cartherics CEO Professor Alan Trounson AO said the completion of the cleanrooms marks a critical milestone for the company’s manufacturing capabilities.
“The completion of the cleanrooms means that clinical manufacturing can now begin for Cartherics’ therapeutic products targeting ovarian cancer and endometriosis,” Prof Trounson said.
“These advanced manufacturing facilities will provide a much needed addition to Victoria’s translational capacity in oncology, regenerative medicine and other therapeutic applications.”
Cartherics said the facility has been fitted with environmental control systems and advanced processing technologies to meet the strict standards required for cell therapy manufacturing.
It includes closed processing systems, bioreactors, cleanroom-grade incubators and a bioburden testing lab, supporting robust and compliant manufacturing processes.
The company said the investment supports its broader mission to develop innovative immunotherapies for diseases such as triple-negative breast cancer, endometriosis, and other conditions with unmet clinical needs.
