09 February 2021 | News
Single-use Bioreactors initiate GMP operation for flexible large-scale manufacturing services
Photo Credit: Freepik
WuXi Biologics, a global company with leading open-access biologics technology platforms, today announced that its MFG5 Drug Substance (DS) manufacturing facility in China has successfully launched GMP operation, with the capacity of 36,000L, deploying nine 4,000L single-use bioreactors. As a major landmark in the company's global capacity planning, the GMP launch of MFG5 brings WuXi Biologics' current capacity to 90,000L, greatly enhancing the capability to enable global partners.
Employing advanced manufacturing and quality systems, this new 70,000m² facility is the largest DS facility within WuXi Biologics' global network, and also the world's largest GMP facility using single-use bioreactors. Leveraging its state-of-the-art design, MFG5 will provide flexible and high-quality manufacturing solutions that cater to a range of customer needs, including different manufacturing scale of 4,000L, 8,000L, 12,000L and 16,000L. The GMP launch of MFG5 showcases WuXi Biologics' industry-leading Scale-out strategy of combining multiple single-use bioreactors for large-scale biologics manufacturing. This approach is more productive and environmentally friendly, compared with using traditional stainless-steel bioreactors.
"I am very proud that we've achieved another milestone as our MFG5 facility begins GMP operation. Our leading expertise in using single-use bioreactors for commercial manufacturing, especially at the scale of 16,000L, can largely reduce manufacturing cost and enable disposable technology to compete effectively with the largest stainless steel facilities in the world." said Dr. Chris Chen, Chief Executive Officer of WuXi Biologics. "As part of our global network, the MFG5 facility significantly increases our total DS capacity. With the robust global network, we're confident to start any project for clients within 4 weeks. Moving ahead, we will continue to improve our capacities and capabilities to enable global partners and benefit patients worldwide."
In the second half of 2021, another line with the capacity of 24,000L (12x2000L) will also be GMP ready, bringing the total capacity of MFG5 to 60,000L.