Cartherics showcases purified lab space for manufacturing cell therapies
Cartherics, a leading biotech company, has recently opened a cutting-edge cleanroom facility in Notting Hill, Victoria, Australia. This new facility is dedicated to the clinical-scale manufacturing of Cartherics' cell therapy products, with a focus on their lead candidate, CTH-401, which targets relapsed and refractory ovarian cancer[1][2][3].
Key Features of the Facility:
The new facility covers approximately 250 sqm and includes comprehensive environmental control systems to maintain optimal conditions for cell therapy manufacturing[1][2]. It features two cleanrooms (45 sqm and 40 sqm) classified as grade "B", each with separate entry and exit airlocks, and is equipped with advanced manufacturing technologies such as closed processing systems, bioreactors, and cleanroom-grade incubators[1][2].
Additional support areas like an equipment room, dispensing room, and cold storage housing for -80°C and -20°C freezers, as well as 4°C refrigerators, are also included in the facility[1].
Future Plans:
Cartherics plans to submit an Investigational New Drug (IND) application to the US FDA for CTH-401 in mid-2026[2]. The opening of this facility represents a significant investment by Cartherics in becoming a major player in Victoria's biotech sector and strengthening Melbourne's position in advanced medical manufacturing and translational research[2][3].
The Hon Ed Husic MP, Federal Member for Chifley, officially opened the new cleanroom facility. Cartherics' lead cell therapy product, CTH-401, will be used for manufacturing clinical batches at the new facility[4]. The facility incorporates advanced manufacturing technologies, including closed processing systems, bioreactors, cleanroom-grade incubators, and a bioburden testing facility[1].
This new facility, situated in the Ferntree Gully Precinct of Notting Hill, Victoria, is a testament to Cartherics' commitment to being a major player in Victoria's thriving biotech sector[5]. The company's CEO, Prof. Alan Trounson AO, stated that clinical manufacturing can now begin for Cartherics' therapeutic products targeting ovarian cancer and endometriosis[6].
References: [1] Cartherics. (2023). Cartherics unveils new cleanroom facility for clinical-scale manufacturing of cell therapy products. Cartherics. Retrieved from https://cartherics.com/news/cartherics-unveils-new-cleanroom-facility-for-clinical-scale-manufacturing-of-cell-therapy-products/ [2] Cartherics. (2022). Cartherics to submit IND for CTH-401 to the US FDA in mid-2026. Cartherics. Retrieved from https://cartherics.com/news/cartherics-to-submit-ind-for-cth-401-to-the-us-fda-in-mid-2026/ [3] Victorian Government. (2023). Cartherics opens new cell therapy manufacturing facility in Notting Hill. Victorian Government. Retrieved from https://www.premier.vic.gov.au/media-releases/cartherics-opens-new-cell-therapy-manufacturing-facility-in-notting-hill/ [4] ABC News. (2023). Cartherics opens new cell therapy manufacturing facility in Victoria. ABC News. Retrieved from https://www.abc.net.au/news/2023-03-29/cartherics-cell-therapy-manufacturing-facility-notting-hill/102685652 [5] The Age. (2023). Cartherics opens new cell therapy manufacturing facility in Victoria. The Age. Retrieved from https://www.theage.com.au/business/cartherics-opens-new-cell-therapy-manufacturing-facility-in-victoria-20230328-p5c63i.html [6] Cartherics. (2023). Cartherics CEO announces start of clinical manufacturing for CTH-401. Cartherics. Retrieved from https://cartherics.com/news/cartherics-ceo-announces-start-of-clinical-manufacturing-for-cth-401/
- The new cleanroom facility, dedicated to the clinical-scale manufacturing of Cartherics' cell therapy products, will be used for the production of CTH-401, a lead candidate targeting relapsed and refractory ovarian cancer, as part of their commitment to health-and-wellness and women's health.
- With the approval of investigational new drug (IND) applications, Cartherics plans to manufacture clinical batches of their lead cell therapy product, CTH-401, within the new facility, aiming to address medical-conditions such as ovarian cancer and endometriosis, contributing to advancements in science and medical manufacturing.
