Cell Therapies Pty Ltd, a leading provider of cell and gene therapy products in the Asia Pacific region, is proud to announce that its proprietary facility has been accredited by the Ministry of Health, Labour and Welfare (MHLW), the regulatory body that oversees food and drugs in Japan, as a certified foreign regenerative, cellular therapy and gene therapy products manufacturer.
The certificate of accreditation was signed on 11 June 2021 by the Japanese Minister of Health, Labour and Welfare, and is issued in accordance with the Act on Securing Quality, Efficacy and Safety of Pharmaceuticals, Medical Devices, Regenerative and Cellular Therapy Products, Gene Therapy Products, and Cosmetics.
Cell Therapies’ newly certified 10-cleanroom facility is located at the Peter MacCallum Cancer Centre in Melbourne, Australia, and is already licensed by the Australian Therapeutic Goods Administration (TGA) for cGMP manufacturing of T-cell products for commercial supply and clinical trials.
Today’s accreditation is the most recent act of recognition of Cell Therapies’ highest regulatory, compliance, and quality standards, and an important milestone in our aspiring journey to supplying ground-breaking cell & gene therapies to the global market.
