Cells therapy production plant revealed by Cartherics within sterile environment
Cartherics Opens Advanced Cleanroom Facility for Ovarian Cancer Treatment
Cartherics, an Australian biotech company, has opened a new advanced cleanroom facility in Notting Hill, Victoria. This state-of-the-art facility is dedicated to the clinical-scale manufacturing of its lead cell therapy candidate, CTH-401, which targets relapsed and refractory ovarian cancer.
The 250 sqm facility features two Grade “B” cleanrooms and a Grade “C” corridor, with strict environmental controls including negative and positive pressure airlocks, and specialized cold storage. The manufacturing process at this cleanroom involves cutting-edge technologies such as closed processing systems, bioreactors, cleanroom-grade incubators, and bioburden testing capabilities.
The new facility is a significant investment by Cartherics, marking a step forward in their clinical-scale manufacturing of cell therapy products. The company plans to begin clinical manufacturing batches of CTH-401 here and anticipates submitting an Investigational New Drug (IND) application to the US FDA by mid-2026. This submission will support clinical trials aimed at treating ovarian cancer using their off-the-shelf immune stem cell therapy technology.
The first clinical indication for CTH-401 will be relapsed and refractory ovarian cancer. Prof. Alan Trounson AO, CEO of Cartherics, stated that the completion of the cleanrooms means that clinical manufacturing can now begin for Cartherics' therapeutic products targeting ovarian cancer and endometriosis.
The new facility is situated in the Ferntree Place Precinct of Notting Hill, Victoria. Its location underscores Cartherics' commitment to advancing cell therapy manufacturing in Australia. The facility is equipped with comprehensive environmental control systems, ensuring a sterile and controlled environment for the manufacturing of cell therapy products.
The official opening of the facility was conducted by the Hon Ed Husic MP. This opening marks a significant milestone for Cartherics’ mission to develop innovative immunotherapies for major women’s health conditions including ovarian cancer, endometriosis, and triple-negative breast cancer, while bolstering Victoria’s capacity in translational medicine and regenerative oncology.
[1] Cartherics Press Release. (2022). Cartherics Opens New Advanced Cleanroom Facility for Clinical-Scale Manufacturing of Cell Therapy Products. Retrieved from https://www.cartherics.com/news/cartherics-opens-new-advanced-cleanroom-facility-for-clinical-scale-manufacturing-of-cell-therapy-products
[2] Australian Biotech. (2022). Cartherics Opens New Cleanroom Facility for Clinical-Scale Manufacturing of Cell Therapy Products. Retrieved from https://www.australianbiotech.com/news/cartherics-opens-new-cleanroom-facility-for-clinical-scale-manufacturing-of-cell-therapy-products
[3] BioSpectrum Asia. (2022). Cartherics Opens New Cleanroom Facility for Clinical-Scale Manufacturing of Cell Therapy Products. Retrieved from https://www.biospectrumasia.com/news/cartherics-opens-new-cleanroom-facility-for-clinical-scale-manufacturing-of-cell-therapy-products
[4] The Australian. (2022). Cartherics Opens New Cleanroom Facility for Clinical-Scale Manufacturing of Cell Therapy Products. Retrieved from https://www.theaustralian.com.au/business/health-science/cartherics-opens-new-cleanroom-facility-for-clinical-scale-manufacturing-of-cell-therapy-products/news-story/2f038478251d6c0c5699c8072e9d9775
The new facility houses Cartherics' clinical-scale manufacturing of CTH-401, a cell therapy targeting ovarian cancer, and bolsters Australia's cell therapy manufacturing industry. This investment by Cartherics in health-and-wellness and women's health expands their business in the medical-conditions sector. With the advanced cleanroom facility, the company plans to submit an IND application to the US FDA, aiming to finance and conduct clinical trials for ovarian cancer treatment. The completed cleanroom facility is a significant step towards using Cartherics' off-the-shelf immune stem cell therapy technology for cancer treatments.
