Tessa Therapeutics to Open 90,000 Square Foot Commercial-Scale Cell Therapy Manufacturing Facility in Singapore in 2020

PR82241

SINGAPORE, Dec. 19, 2019 /PRNewswire=KYODO JBN/ --

- 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

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.

Tessa Therapeutics Media Contacts

Gladys Wong

gladyswong@tessatherapeutics.com

+65-6384-0755

Zara Lockshin

Solebury Trout

zlockshin@troutgroup.com

+1-646-378-2960

source: Tessa Therapeutics