- State-of-the-art manufacturing facility will support clinical and commercial production of cell therapies for thousands of patients annually worldwide
- Global commercial-scale facility is designed to comply with cGMP guidelines in the U.S., Europe and Asia
- Facility will integrate digital technology to enable real-time monitoring of manufacturing and vein-to-vein supply chain logistics
Singapore /PRNewswire/ - Tessa Therapeutics (Tessa), a clinical-stage cell therapy company focused on the development of innovative cell therapies to treat cancer, today announced plans to open a 90,000 square foot commercial-scale cell therapy manufacturing facility in Singapore by end-2020, which will be one of the leading commercial-scale cell therapy manufacturing facilities in Asia.
Notably, the state-of-the-art facility will be built to run both clinical and commercial manufacturing of cell therapy products that is compliant with current Good-Manufacturing-Practice (cGMP) guidelines from the U.S. Food and Drug Administration, European Medicines Agency and key regulators in Asia.
"This facility will strengthen our ability to bring innovative cell therapies to thousands of patients around the world," said John Ng, Chief Operations Officer of Tessa Therapeutics. "As one of very few manufacturing facilities globally designed with the capabilities to meet clinical trial and registration requirements from multiple geographies, Tessa is poised to rapidly advance its role as a leading innovator of next-generation cancer cell therapies."
Operationally, the facility will integrate digital technology to monitor, in real-time, its manufacturing operations and vein-to-vein supply chain logistics. The ability to digitally manage the complex process involved in delivering cell therapies to patients worldwide will not only enhance the traceability and control of patient material, but also enable greater standardization, scalability and quality management across its operations. This ultimately translates into better decision-making and coordination at the hospital sites for improved patient care.
The new facility will expand on the company's proven record of successful global cell therapy manufacturing, shipments, and infusions to patients in a Phase III clinical trial setting. Currently, the Company has produced and delivered autologous, personalized cell therapies to more than 100 patients in 30 clinical sites across five countries. The new manufacturing facility will enable Tessa to deliver its cell therapies faster and more reliably.
The new facility will also build out Tessa's in-house process development capabilities and serve as a centre of excellence to advance CMC (Chemistry, Manufacturing and Controls) development efforts of its cell therapies from early phase clinical development through to commercialization.
The entire manufacturing hub, totalling 130,000 square feet, will include office space to house Tessa's Corporate Headquarters. Tessa has entered into a lease agreement to develop the facility within an existing high-tech industrial building in Singapore.
About Tessa Therapeutics
Tessa Therapeutics is a clinical-stage biotechnology company focused on the development of cell therapies for lymphomas and solid tumors. Tessa's Virus-Specific T cell (VST platform) has shown a strong safety profile and early efficacy in the treatment of solid tumors.
Tessa is currently conducting two pivotal studies of autologous cell therapies in nasopharyngeal cancer and classical Hodgkin lymphoma. Tessa also has an earlier-stage clinical pipeline of autologous and off-the-shelf, allogeneic therapies targeting a wide range of cancers.
The Company has built robust operational and supply chain capabilities, across Asia and the United States, to successfully deliver cell therapies on a global scale, creating a fully integrated approach to the treatment of cancer.
For more information on Tessa, please visit www.tessatherapeutics.com.