BeiGene to build late-stage clinical and commercial production capacity for cancer monoclonal antibodies with GE Healthcare’s KUBio, the prefabricated biopharma facility based on single-use technologies.
BeiGene, Ltd., a commercial-stage biotechnology company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, has selected GE Healthcare Life Sciences’ off-the-shelf biomanufacturing facility, KUBio for large-scale production of its cancer monoclonal antibodies (mAbs).
The KUBio will be located in Guangzhou, the capital city of Guangdong Province, China, where an increasing number of biotech firms are establishing operations. The first phase of the facility is expected to be completed and operational in 2019. BeiGene is already using GE Healthcare’s FlexFactory, an integrated biomanufacturing platform in its existing manufacturing plant in Suzhou, China to manufacture mAbs for clinical trials.
“To realize our mission of developing innovative solutions to help cancer patients in China and globally, BeiGene is constantly focused on quality and agility, not only in R&D, but also in manufacturing. We believe that the implementation of the KUBio facility will help us to produce antibody-based medicines with a high standard of quality to address the unmet and urgent needs of cancer patients,” said Jonathan Liu, Ph.D., Senior Vice President, Biomanufacturing and Head of Biologics of BeiGene.
“BeiGene is one of the leading biotechnology companies from China, striving to serve patients with new cancer therapies worldwide. We believe that KUBio will help BeiGene to reach the China and global markets more quickly, using a flexible and reliable manufacturing platform that meets the highest regulatory standards,” said Olivier Loeillot, General Manager, BioProcess, GE Healthcare Life Sciences.
GE Healthcare’s KUBio can be constructed, assembled and fully fitted-out to current Good Manufacturing Practices (cGMP) standards in approximately 18 months, which is up to 50 percent faster than traditional manufacturing facilities that usually require approximately three years before they are fully commissioned and qualified. The facility is based on the single-use technologies that bring flexibility and are designed to yield higher productivity by increasing the number of lots manufactured, reducing maintenance requirements and shortening downtime between batches and products. GE Healthcare Life Sciences has delivered three KUBios to China and over 50 FlexFactories globally.
BeiGene is a global, commercial-stage, research-based biotechnology company focused on molecularly-targeted and immuno-oncology cancer therapeutics. With a team of over 1,300 employees in China, the United States, Australia and Switzerland, BeiGene is advancing a pipeline consisting of novel oral small molecules and monoclonal antibodies for cancer. BeiGene is also working to create combination solutions aimed to have both a meaningful and lasting impact on cancer patients. BeiGene markets ABRAXANE® (nanoparticle albumin–bound paclitaxel), REVLIMID® (lenalidomide), and VIDAZA® (azacitidine) in China under a license from Celgene Corporation.[i]. For more information, please visit our website at www.beigene.com.
[i] ABRAXANE®, REVLIMID®, and VIDAZA® are registered trademarks of Celgene Corporation.
Forward-Looking Statements of BeiGene
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding BeiGene’s manufacturing plans and capabilities and the advancement of, and anticipated clinical development, regulatory milestones and commercialization of its drug candidates. Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including BeiGene's ability to demonstrate the efficacy and safety of its drug candidates; the clinical results for its drug candidates, which may not support further development or marketing approval; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials and marketing approval; BeiGene's ability to achieve commercial success for its marketed products and drug candidates, if approved; BeiGene's ability to obtain and maintain protection of intellectual property for its technology and drugs; BeiGene's reliance on third parties to conduct drug development, manufacturing and other services; BeiGene’s limited operating history and BeiGene's ability to obtain additional funding for operations and to complete the development and commercialization of its drug candidates, as well as those risks more fully discussed in the section entitled “Risk Factors” in BeiGene’s most recent quarterly report on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in BeiGene's subsequent filings with the U.S. Securities and Exchange Commission. All information in this press release is as of the date of this press release, and BeiGene undertakes no duty to update such information unless required by law.