uBriGene, a cell & gene therapy contract development and manufacturing organization (CDMO), is expanding into the US market with the acquisition of a state-of-the-art GMP manufacturing facility from NASDAQ-listed company Mustang Bio, Inc.
The cell & gene therapy (CGT) CDMO has an established global footprint with two GMP manufacturing facilities in China and its headquarters in Vancouver, Canada. The latest move will see uBriGene expand its global headcount to over 500 employees.
The newly acquired manufacturing site in Worcester, Boston, Massachusetts, has a suite of clinical facilities for the production of cell and gene therapies, as well as providing contract analytical services.
The 27,000 square foot site is designed for multiproduct cGMP manufacturing of multiple gene-modified cell types and has fully integrated technology transfer, quality control testing, manufacturing development, warehousing, and cGMP storage capabilities. The site has successfully manufactured two different CAR-T products to support clinical trials and has performed extensive analytical and process development work to support the products.
"This acquisition is important to uBriGene's commitment to support the development, clinical, and commercial supply of cell and gene therapies to meet rapidly growing demand," said Alex Chen, President of uBriGene. "We hope to work together with the University of Massachusetts Medical School to continue to grow the advanced therapy manufacturing ecosystem in the Worcester region.
This partnership enables us to expand rapidly to create a North American presence and offer the same high-quality cell and gene therapy development and manufacturing capabilities for the U.S. that we currently provide in Asia, including to support Mustang Bio's lead clinical-stage CAR-T program."
The newly acquired facilities have been developed to a very high-quality standard with a cGMP-compliant quality system.
"Mustang is excited to be partnering with uBriGene to advance our novel leading cell therapy programs and leverage their global manufacturing and development expertise to progress our advanced cellular therapies through clinical trials in the United States," said Manny Litchman, Mustang Bio's Chief Executive Officer.
As part of the purchase, uBriGene will take over the clinical manufacturing of Mustang Bio's MB-106, a CAR-T cell therapy treatment for a wide range of hematologic malignancies, including Waldenstrom macroglobulinemia, a rare malignant disorder of the bone marrow and lymphatic tissues, which could improve the lives of patients if successful.
The move is set to generate significant high-value job creation and growth opportunities in the greater Boston area. uBriGene is looking to expand its team at the site further by hiring more than 50 new technical specialists over the next 12 months. The facility is located in close proximity to the University of Massachusetts Chan Medical School and other renowned technical universities which will enable uBriGene to draw on the world-class skills and talent available on the doorstep.
uBriGene Biosciences Inc. is dedicated to providing one-stop viral vector-based CDMO services for research and clinical applications. It has established integrated innovative biologics CDMO platforms that provide GMP-level plasmid preparation, viral packaging, and T-cell production services for large-scale CAR-T productions.
In addition, the company also provides viral vectors, including adenoviral and lentiviral vectors to meet the demands of research and/or manufacturing applications.
With its fermentation capacity ranging from 5L to 500L, uBriGene offers a versatile selection of research-grade, GMP-ready, or GMP-grade plasmids for research and clinical applications respectively.
uBriGene currently operates two state-of-the-art GMP facilities, including 21 clean suites with a total area of over 133,000 sq ft.
For more information, visit www.ubrigene.com