First GMP Production at 24,000L Line of MFG5 Facility Successfully Completed at WuXi Biologics
- MFG5 60,000L capacity is all put in use. Total capacity increased to 150,000L to support late-phase and commercial manufacturing projects.
Wuxi, China, November 23, 2021 – WuXi Biologics (“WuXi Bio”) (2269.HK), a global company with leading open-access biologics technology platforms, announced that it has successfully completed the first GMP production at the new 24,000L line of its drug substance facility MFG5. This follows the initial GMP operations of the 36,000L biomanufacturing line of MFG5 this February. With its total 60,000L capacity, MFG5 will further support the growing demand for manufacture of late-phase and commercial projects across multiple modalities, such as monoclonal antibodies, bispecifics and fusion proteins. As a result, there is a total of approximately 150,000L biomanfacturing capacity at WuXi Biologics, which makes the company holding Top 5 capacity in the global CDMOs.
The new 24,000L line utilizes the scale-out strategy combining twelve 2000L single-use bioreactors to enable the various production processes — including fed-batch, perfusion and CFB — at different scales, ranging from 2,000L to 12,000L. In addition, the implementation of WuXiUP™ continuous downstream technology in the 24,000L line for commercial production will allow MFG5 to increase productivity and reduce Cost of Goods Sold (COGS).
“We’re excited that the MFG5 facility is delivering even more high-quality services to our clients for advancing biologic therapies towards regulatory approvals and commercialization. As one of the largest cGMP biologics manufacturing facilities in the world to employ only single-use bioreactors, MFG5 has comparable cost structure as any current largest biologics facilities running up to 25,000L scale.” said Dr. Chris Chen, CEO of WuXi Biologics. “The demand for commercial manufacturing from global companies has been growing fast due to the success of our ‘follow and win-the-molecule’ strategy. We are committed to expanding our capacity and capabilities in response to the market and look forward to supporting the development and manufacture of life-saving treatments to benefit patients worldwide.”
The WuXiUP™, a continuous manufacturing bioprocessing platform based on intensified perfusion culture processes, is developed as a next-generation biomanufacturing solution that provides high-yield, high-quality drug products while being highly flexible and cost-effective. The breakthrough WuXiUP™ process couples continuous cell culture operations with continuous column chromatography, while also achieving purification yields similar to or higher than traditional step-wise unit operation purification processes.
WuXiUP™ has successfully enabled over 40 projects including mAbs, bispecifics, fusion proteins and enzymes to realize 6.6 folds of average titer improvement in productivity, six of which have been cleared for clinical trials and three of which have been submitted Biologics License Application, with one approved in China.
About WuXi Biologics
WuXi Biologics (stock code: 2269.HK), a Hong Kong-listed company, is a leading global open-access biologics technology platform offering end-to-end solutions to empower organizations to discover, develop, and manufacture biologics from concept to commercial manufacturing. The company’s history and achievements demonstrate its commitment to providing a truly ONE-stop service offering and strong value proposition to its global clients.
The company is currently conducting on behalf of its clients and partners (as of June 30, 2021) a total of 408 integrated projects, including: 212 in pre-clinical development stage; 160 in early-phase (phase I and II) clinical development; 32 in late-phase (phase III) development; and 4 in commercial manufacturing. With a total estimated capacity exceeding 430,000 liters for biopharmaceutical production planned after 2024 in China, Ireland, the U.S., Germany, and Singapore, WuXi Biologics will continue to provide its biomanufacturing partners with a robust and premier-quality global supply chain network.
WuXi Biologics views Environmental, Social, and Governance (ESG) responsibilities as an integral component of its ethos and business strategy and aims to become a global ESG leader in biologics manufacturing. We use next-generation clean biomanufacturing technologies and utilize cleaner energy sources. We have also established an ESG committee led by the CEO to increase efficiency while advancing our commitment to sustainability. For more information about WuXi Biologics, please visit: www.wuxibiologics.com.