The World's Largest 36,000L Biomanufacturing Line Using Single-use Bioreactors Launches GMP Operation at WuXi Biologics

Rhea-AI Summary

WuXi Biologics has launched GMP operations at its MFG5 Drug Substance manufacturing facility in China, increasing its capacity to 90,000L. The facility features nine 4,000L single-use bioreactors and is the largest of its kind globally. WuXi’s advanced Scale-out strategy allows for flexible manufacturing solutions, promising to initiate projects within four weeks. An additional 24,000L line will add capacity later in 2021, bringing MFG5's total to 60,000L. This expansion reflects WuXi’s commitment to enhancing its biomanufacturing capabilities.

Positive

• Launch of GMP operations increases total manufacturing capacity to 90,000L.
• MFG5 is the largest GMP facility worldwide using single-use bioreactors.
• Capacity expansion allows initiation of projects within four weeks.
• Upcoming addition of a 24,000L line will further increase capacity to 60,000L.

Negative

• None.

• Greatly increase the company's current capacity to 90,000L and enable WuXi Biologics to initiate any project within four weeks
• Offer flexible large-scale manufacturing services by implementing Scale-out strategy

WUXI, China, Feb. 8, 2021 /PRNewswire/ -- WuXi Biologics ("WuXi Bio") (2269.HK), 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. 

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. As of June 30, 2020, there were a total of 286 integrated projects, including 141 projects in pre-clinical development stage, 125 projects in early-phase (phase I and II) clinical development, 19 projects in late-phase (phase III) development and one project in commercial manufacturing. With total estimated capacity for biopharmaceutical production planned in China, Ireland, the U.S., Germany, and Singapore exceeding 300,000 liters after 2023, WuXi Biologics will provide its biomanufacturing partners with a robust and premier-quality global supply chain network. For more information about WuXi Biologics, please visit: www.wuxibiologics.com.

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SOURCE WuXi Biologics

FAQ

What is the significance of the MFG5 facility launch for WuXi Biologics?

The launch increases WuXi Biologics' manufacturing capacity to 90,000L, enhancing its ability to support global partners.

What technology does the MFG5 facility utilize?

The facility uses single-use bioreactors and employs a Scale-out strategy for efficient large-scale biologics manufacturing.

When will the additional capacity for the MFG5 facility be available?

An additional 24,000L line will be GMP ready in the second half of 2021, increasing the total capacity to 60,000L.

How quickly can WuXi Biologics start new projects after the MFG5 launch?

WuXi Biologics can initiate projects within four weeks due to the enhanced capacity of the MFG5 facility.

What previous capacities did WuXi Biologics have before the MFG5 launch?

Before the MFG5 launch, WuXi Biologics had a capacity of 36,000L, which has now increased to 90,000L.