Tessa Therapeutics (Tessa), a Singapore-based clinical-stage cell therapy company, has unveiled plans to open a 90,000 square foot commercial-scale cell therapy manufacturing facility on the island by end-2020. The company believes it will become one of the leading facilities in Asia.
The facility will be built to run both clinical and commercial manufacturing of cell therapy products that are compliant with current GMP guidelines from the US Food and Drug Administration, the European Medicines Agency and key regulators in Asia.
“As one of the 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," said John Ng, Chief Operations Officer of Tessa Therapeutics.
The entire manufacturing hub, totalling 130,000 sqft, will include office space to house Tessa’s Corporate Headquarters.
Manufacturing operations
Tessa said 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 standardisation, 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 company said.
The new facility will expand on the company’s global cell therapy manufacturing, shipments, and infusions to patients in a Phase III clinical trial setting.
Currently, Tessa has produced and delivered autologous, personalised 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.
Chemistry, manufacturing and controls
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 commercialisation.
Tessa has entered into a lease agreement to develop the facility within an existing hi-tech industrial building in Singapore.
