News & Views
BeiGene Selects GE Healthcare’s Off-the-Shelf Biologics Factory to Boost its Manufacturing Capacity for Cancer Drugs
Sep 18 2018 Read 1026 Times
BeiGene, Ltd 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 realise 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, PhD, 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% 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.
Do you like or dislike what you have read? Why not post a comment to tell others / the manufacturer and our Editor what you think. To leave comments please complete the form below. Providing the content is approved, your comment will be on screen in less than 24 hours. Leaving comments on product information and articles can assist with future editorial and article content. Post questions, thoughts or simply whether you like the content.
In This Edition Mass Spectrometry & Spectroscopy - 67th ASMS Conference on Mass Spectrometry and Allied Topics - Modular MS Bench System with Integrated Gas Supply for Sciex LC-MS/MS Unveile...
View all digital editions
Aug 04 2019 Anaheim, CA, USA
Aug 04 2019 Portland, OR, USA
Aug 05 2019 Lombard, IL, USA
Aug 25 2019 San Diego, CA, USA
Sep 01 2019 Berlin, Germany