Cartherics, an Australia-based biotechnology company, has opened a new cleanroom facility dedicated to clinical-scale manufacturing of its cell therapy products.
Cartherics specialises in developing off-the-shelf immune stem cell therapies targeting high-impact women’s diseases, including ovarian cancer and endometriosis.
The newly inaugurated cleanroom will initially support the production of clinical batches of the company’s lead cell therapy candidate, CTH-401, intended for the treatment of relapsed and refractory ovarian cancer.
The newly inaugurated cleanroom will initially support the production of clinical batches of the company’s lead cell therapy candidate, CTH-401
The company exclusively shared with Cleanroom Technology, the facility covers approximately 250 sqm and features a comprehensive layout designed to maintain strict environmental controls.
The layout includes entry airlocks operating under negative pressure for full containment, two change rooms, and a gowning area leading to a centrally classified “C” grade corridor.
This corridor provides access to an equipment room, dispensing room, and cold storage housing -80°C and -20°C freezers as well as 4°C refrigerators. Separate entry and exit airlocks serve each cleanroom, both classified as grade “B”.
The two cleanrooms measure 45 sqm and 40 sqm respectively, with all internal areas maintained under positive pressure.
Exclusively shared with Cleanroom Technology, the facility covers approximately 250 sqm
There is a minimum pressure differential of 15-20 pascals between each area, while the inner cleanrooms maintain +50 pascals above the external environment.
Each cleanroom is HEPA filtered and equipped with HEPA-filtered pass-throughs for controlled entry and exit of products, equipment, and supplies.
The “C” grade corridor also has dual HEPA-filtered pass-throughs to ensure facility integrity.
The facility includes a quality control (QC) room for continuous monitoring of bioburden (bacteria, viruses, etc.) through settling and touch plates, as well as a controlled environment storage room for consumables.
Each cleanroom is HEPA filtered and equipped with HEPA-filtered pass-throughs for controlled entry and exit of products, equipment, and supplies
Notably, Cartherics decided against using isolators based on prior experience.
Each cleanroom is rated as a “B” grade environment, providing an appropriate background level of cleanliness for the use of Biological Safety Cabinets (BSCs).
These cabinets create an “A” grade interior work environment. Both cleanrooms undergo continuous monitoring for particle counts per cubic metre, pressure, airflow, temperature, and humidity.
Each BSC contains an inbuilt particle counter monitoring the cabinet environment; a three-level warning system alerts operators if any parameter approaches critical thresholds, allowing for prompt corrective action.
BioConstruct Services was responsible for the cleanroom construction, while Cartherics undertook the design and specification of the facility.
The facility includes a quality control room for continuous monitoring of bioburden
Prof Alan Trounson AO, CEO of Cartherics, said: “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.”
Cartherics is committed to transforming care in women’s health by developing innovative immunotherapies for conditions such as ovarian cancer, triple-negative breast cancer, endometriosis, and other underserved diseases.
The company plans to submit an Investigational New Drug (IND) application for CTH-401 to the US Food and Drug Administration (FDA) in mid-2026.