In 2021, C-Ray Therapeutics began to build its R&D and Manufacturing Center in Wenjiang district of Chengdu. As an ideal location for receiving inbound radionuclide shipment and sending outgoing national deliveries nationally, the site is designed as State-of-the-art, fully equipped, to maximize the efficiency of complex manufacturing workflows, with all support areas surrounding a large, centralized cleanroom space.
This site will be built in three phases. The first phase is designed to enable the radiopharmaceutical research and development, from process development, analytical method development, quality development, to early-stage manufacturing for Phase 1/2 trials. It will also support the tech transfer and validation for partners’ products localization. 15 production suites including PET/SPECT imaging products and beta and alpha emitter therapeutic radiopharmaceuticals production for late stage and commercial manufacturing will also be included with automated radiolabeling procedures, fill and dispensing. There will be also dedicated packaging and logistics coordination, including direct ordering from end-users.
Based on the company strategic needs, the Phase two and Phase three construction plan to extend various technology platforms to enable R&D collaborations, promote translational medicine, combined with the molecular imaging technology and biological evaluation capacities. We will further scale-up the production capability to cover a full life cycle from chemistry development late stage manufacturing.
Dedicated to the high quality development, manufacturing and distribution of therapeutic and diagnostic radiopharmaceuticals. the infrastructure will be able to support the R&D, clinical trial and commercial scale supply with high volume production & fill/finish lines, QC laboratories, warehouse and distribution center.
The facility is designed to cover a building area of 860,000 ft² (300,000 ft² of the first phase).
Designed and built in-compliance with China’s GMP standard as well as US FDA and EMA cGMP standards to support development and commercial scale supply.
Licensed includes various emitters operation, a flexible and scalable R&D space to enable the preclinical and translational development of radiopharmaceuticals.
Dedicated to the high quality development, manufacturing and distribution of therapeutic and diagnostic radiopharmaceuticals. the infrastructure will be able to support the R&D, clinical trial and commercial scale supply with high volume production & fill/finish lines, QC laboratories, warehouse and distribution center.
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