Cartherics Pty Ltd., a biotechnology company developing off-the-shelf immune stem cell therapies focusing on high-impact women’s diseases, with lead programs in ovarian cancer and endometriosis, has unveiled its new, state-of-the-art cleanroom facility for clinical-scale manufacturing of cell therapy products.

The facility was officially opened by the Ed Husic, MP, Federal Member for Chifley, at a special event attended by key stakeholders and industry partners.

Once validated, the facility will be used for manufacturing of clinical batches of the company’s lead cell therapy product, CTH-401, for which the first clinical indication will be relapsed and refractory ovarian cancer.

Cartherics is working towards its mission to transform care in women’s health with innovative off-the-shelf immunotherapies, offering new hope for conditions like ovarian cancer, triple negative breast cancer, endometriosis, and other underserved diseases. It anticipates submitting an IND for CTH-401 to the US FDA in mid-2026.

Cartherics’ CEO, Prof. Alan Trounson AO, commented, “The completion of the  cleanrooms means that clinical manufacturing can now begin for Cartherics’ therapeutic products targeting ovarian cancer and endometriosis. These advanced manufacturing facilities will provide a much needed addition to Victoria’s translational capacity in oncology, regenerative medicine and other therapeutic applications.”

Situated in the Ferntree Place Precinct of Notting Hill, Victoria, the new facility is equipped with comprehensive environmental control systems which monitor particle counts, airflows, air pressures, humidity, and temperature. It incorporates advanced manufacturing technologies, including closed processing systems, bioreactors, cleanroom-grade incubators and a bioburden testing facility.