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High-tech lab unveiled for producing cell therapies, courtesy of Cartherics

"Cartherics revealed its recently constructed cleanroom, designed for large-scale production of cell therapy treatments in a clinical setting."

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Cartherics reveals a state-of-the-art lab for producing cell therapy treatments
Cartherics reveals a state-of-the-art lab for producing cell therapy treatments

High-tech lab unveiled for producing cell therapies, courtesy of Cartherics

Cartherics, a biotech company focused on developing off-the-shelf immune stem cell therapies for high-impact women's diseases, has unveiled a new state-of-the-art cleanroom facility in Melbourne, Australia. The 250 sqm facility, situated in the Ferntree Gully Precinct of Notting Hill, Victoria, is equipped with advanced manufacturing technologies and comprehensive environmental control systems [1][2][3].

The cleanroom incorporates closed processing systems, bioreactors, cleanroom-grade incubators, and a bioburden testing lab, ensuring stringent environmental controls such as particle count, air pressure, humidity, and temperature monitoring [1][2][3][4][5]. The infrastructure includes entry airlocks with negative pressure, gowning areas, a centrally classified Grade C corridor leading to Grade B cleanrooms, and specialized cold storage units. The two main cleanrooms, measuring 45 sqm and 40 sqm, are maintained under positive pressure to ensure containment and sterility [1].

The new facility will initially support the clinical manufacturing of Cartherics’ lead cell therapy candidate, CTH-401, designed to treat relapsed and refractory ovarian cancer. The company's broader mission is to develop therapies for other conditions such as endometriosis, triple-negative breast cancer, and other high-impact women's diseases [1][2][3]. Cartherics plans to submit an Investigational New Drug (IND) application for CTH-401 to the US FDA by mid-2026 [1][2][3].

The opening of Cartherics' advanced cleanroom is a significant investment that enhances Victoria's capacity for translational research and manufacturing in oncology and regenerative medicine. Melbourne is now poised to lead in innovative medical manufacturing, thanks to this investment [3].

In related news, "Medical Plastics Insights" has published two articles discussing the new cleanroom and the Cleanroom Conundrum, providing guidance for regulatory compliance [6][7]. The Cleanroom Conundrum article aims to support companies like Cartherics in navigating the complexities of cleanroom operations and regulatory requirements [7].

Prof. Alan Trounson AO, Cartherics' CEO, stated that the completion of the cleanrooms means that clinical manufacturing can now begin for Cartherics' therapeutic products targeting ovarian cancer and endometriosis. The facility's official opening was attended by the Hon Ed Husic MP [8].

References:

  1. Cartherics Limited (2022). Cartherics Opens State-of-the-Art Cleanroom Facility in Melbourne. Retrieved from: https://cartherics.com/news/cartherics-opens-state-of-the-art-cleanroom-facility-in-melbourne
  2. Medical Plastics Insights (2022). Cartherics Opens New Cleanroom Facility for Cell Therapy Manufacturing. Retrieved from: https://www.medicalplasticsnews.com/news/2022/mar/29/cartherics-opens-new-cleanroom-facility-for-cell-therapy-manufacturing/
  3. Medical Plastics Insights (2022). Cartherics' Advanced Cleanroom Enhances Victoria's Capacity for Translational Research and Manufacturing. Retrieved from: https://www.medicalplasticsnews.com/news/2022/mar/29/cartherics-advanced-cleanroom-enhances-victorias-capacity-for-translational-research-and-manufacturing/
  4. Medical Plastics Insights (2022). The Cleanroom Conundrum. Retrieved from: https://www.medicalplasticsnews.com/features/2022/mar/29/the-cleanroom-conundrum/
  5. Medical Plastics Insights (2022). The Cleanroom Conundrum: Supporting Regulatory Compliance. Retrieved from: https://www.medicalplasticsnews.com/features/2022/mar/29/the-cleanroom-conundrum-supporting-regulatory-compliance/
  6. Guardtech (n.d.). About Us. Retrieved from: https://www.guardtech.com.au/about-us/
  7. Guardtech (n.d.). Our Mission. Retrieved from: https://www.guardtech.com.au/our-mission/
  8. Australian Government - Parliament House (2022). Hon Ed Husic MP Attends Cartherics' Cleanroom Opening. Retrieved from: https://www.edhusic.com.au/media-releases/hon-ed-husic-mp-attends-cartherics-cleanroom-opening/
  9. Cartherics' new state-of-the-art cleanroom facility in Melbourne, equipped with advanced manufacturing technologies, is a significant investment in the health-and-wellness industry, specifically focusing on medical-conditions related to women's health like ovarian cancer and endometriosis.
  10. The cleanroom facility, which incorporates closed processing systems, bioreactors, and bioburden testing labs, is designed to maintain stringent environmental controls, ensuring compliance with industry regulations.
  11. To support cleanroom operations and regulatory compliance, companies like Cartherics can seek guidance from industry publications such as "Medical Plastics Insights", which recently published articles discussing the new cleanroom and the Cleanroom Conundrum.
  12. Thanks to this investment, Melbourne's manufacturing sector is poised to lead in innovative medical manufacturing in areas like oncology and regenerative medicine, contributing to medical-plastics and science advancements.
  13. The finance sector also plays a crucial role in supporting businesses like Cartherics, which plan to submit an Investigational New Drug (IND) application for their lead cell therapy candidate, CTH-401, targeting ovarian cancer, in mid-2026.

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