CARsgen Therapeutics picks CRB for first cGMP foray into the US

Published: 22-Feb-2022

CRB has provided modular cleanroom solutions for the cell and gene therapy space

CARsgen Therapeutics, a company mainly focused on innovative CAR T-cell therapies for the treatment of hematologic malignancies and solid tumours, has opened the newly completed 37,000 sqft clinical and early-stage commercial manufacturing facility.

This is the first manufacturing facility in North America for the Shanghai-based corporation.

CRB, an international leader in sustainable engineering, architecture, construction, and consulting solutions to the life sciences industry, spearheaded the design and construction of the cell & gene therapy space using its ONEsolution approach to deliver the project and meet aggressive goals on schedule and budget.

Using our ONEsolution delivery method enabled us to fast-track and complete the project in just 12 months

Jie Jia, VP of Strategic Alliances and Operations for CARsgen Therapeutics and Ryan Lowden, Project Director for CRB, provided a tour of the new facility for guests, including North Carolina state and local government and economic development officials and business partners, at the grand opening celebration on Friday morning.

The cleanroom spaces in the new facility were built with a unique modular construction system that allowed for an enhanced schedule while meeting the requirements of a controlled environment.

"It has been a privilege to work with CARsgen Therapeutics to deliver this project in support of innovative and differentiated cell therapies for cancer patients. Using our ONEsolution delivery method enabled us to fast-track and complete the project in just 12 months," said Ryan Lowden.

Like this story? Subscribe to Cleanroom Technology magazine for incisive analysis of the latest news and developments in hi-tech industries manufacturing in controlled environments.

"Our new state-of-the art facility expands our global cGMP manufacturing capacity and capability to produce innovative CAR T-cell products for patients in North America and Europe," said Jie Jia. "The facility was designed and built to facilitate the transformation from clinical manufacturing to commercial production so that we can secure drug supply chain and support FDA-cleared Phase 2 CT053 and Phase 1 CT041 clinical studies."

"We're all pleased to celebrate the completion of CARsgen's new manufacturing facility, which is an instrumental step in our global strategy. The RTP manufacturing facility will provide additional production capacity for autologous CAR T-cell products and will support our clinical studies and early commercial launch in North America and Europe. Most of all, it will help CARsgen deliver an effective treatment with substantial survival benefit to the patients around the world," said Zonghai Li, Founder, Chairman of the Board, CEO, and Chief Scientific Officer of CARsgen Therapeutics Holdings.

You may also like