Custom Protein Generation

Drug Substance Manufacture

Drug Product Fill & Finish

Development

Testing

Discovery

Antibody Drug Conjugates

Technologies & Platforms
WuXi Biologics operates multiple world-class GMP manufacturing facilities for the production of biotherapeutics (monoclonal and bispecific antibodies, fusion proteins, antibody drug conjugates and other recombinant proteins) utilizing mammalian cell culture. Over 40,000 L of bioreactor capacity is available for both clinical trials and commercial drug substance supply, growing to 220,000 L by 2022. Clinical-and-commercial-scale drug product GMP manufacture is also available (click here to see Fill & Finish capabilities).

Implementing next-generation facility designs for multi-product facilities, a “scale-out” single-use bioreactor production scheme and continuous bioprocessing technologies, WuXi Biologics has become a leading global biologics supplier for our partners and clients because of our “truly ONE” concept to commercialization drug development platform and excellence in project execution. To see details on each facility, click the corresponding links below:

 

 

 

Each Wuxi Biologics manufacturing facility shares the same Quality System and each site maintains dedicated in-house supporting functions such as QC testing labs, GMP warehouse, bio-waste and waste water treatment, utilities (e.g., HVAC, WFI, Clean Steam etc.), process automation systems (e.g., Delta V + OSI Pi Historian) and two independent power lines and back-up diesel generators.

 


Wuxi city (MFG 1)

Designed and constructed based on U.S., EU and Chinese cGMP requirements and through the review and assistance of several large pharma partners, WuXi Biologics’ first GMP manufacturing bulk drug substance (DS) manufacturing facility utilizing only single-use/disposable bioreactors is available to serve projects on a campaign basis. This 220,000 sq. ft. facility has been fully operational since 2012. The site received an Honorable Mention Facility of the Year Award in 2014 by the International Society for Pharmaceutical Engineering (ISPE) and was approved in 2017 for production of a commercial biologic (see press release).

Site Details

  • Perfusion Cell Culture: 2 x 200 L (ATF6™)
  • Fed-Batch Cell Culture: 200 L, 500 L, 1,000 L, 2 x 2,000 L
  • Separate primary and final purification suites (pre- and post-viral)
  • On-site Drug Product fill & finish (See here for more information)

Case Study

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Wuxi city (MFG 2)

Located just 700 meters down the street from the MFG 1 site, this 460,000 sq. ft. GMP manufacturing facility is compliant with global GMP standards has been operational since 2016 for both large-scale perfusion and fed-batch cell culture manufacturing. As of 2018 the site was the world’s largest manufacturing facility using single-use/disposable bioreactor technology. This site was WuXi Biologics’ first to utilize a “scale-out” approach for large-scale biologics production. To learn more about the advantages of our “scale-out” approach, click here.

Site Details

  • Fed Batch Cell Culture: 2 suites, each with 7 x 2,000 L
  • Perfusion Cell Culture: 1 suite with 2 x 1,000 L (ATF10™)
  • Facility designed by NNE Pharmplan
  • Cost-effective Hybrid Design: (uses single-use bioreactors & stainless steel media/buffer systems)
  • Additional process development labs

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Our Continuous Manufacturing Approach

WuXi Biologics is leading the industry in adoption of continuous bioprocesses. To learn more about our approach, see our on-demand webinar and an industry led Q&A session with our scientists discussing implementation of continuous manufacturing for biologics.

 

Shanghai (MFG 3)

Starting with operations in April, 2018 this 200,000 sq. ft, state-of-the-art center doubled the available cell culture capacity of WuXi Biologics for our client’s clinical GMP manufacturing drug substance supply.  Located next to our biologics discovery and development labs, this site now offers complete one-stop drug development and manufacture in one central location thus streamlining clinical development even further for our clients.

Site Details

  • Fed-Batch Cell Culture: 1 x 200 L, 1 x 1,000 L, 2 x 2,000 L
  • Perfusion Cell Culture: 1 x 200 L / 1 x 500 L (ATF6™), 1 x 1,000 L (ATF10™)
  • Three separate downstream production suites (with pre- and post-viral rooms)
  • 30,000 sq. ft. process development labs
  • Five GMP cell banking suites and storage

 

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Wuxi city (MFG 4, 5 & 9)

These purpose built world-class facilities will be part of a 4 MM sq. ft. biotech hub/campus housing new discovery, development, clinical and commercial GMP manufacturing capacities. This site is in close proximity to our other Wuxi city sites. First manufacturing suites will be operational in 2019 and additional capacities to come on-line through 2020.

Site Details

  • Fed-Batch Cell Culture:
    • 10,000 L (Clinical Production-MFG 4)
    • 10,000 L (Clinical Production-MFG 9)
    • 48,000 L (Initial Commercial Production-MFG 5)
    • Up to 200,000+ L total planned capacity
  • Additional Drug Product Fill and Finish (see here for more details)
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Scale Out vs. Scale Up Commercial Manufacturing

The use of 14 x 2,000 L bioreactors for commercial production is a paradigm changing “scale-out“ philosophy for commercial manufacturing. To understand the philosophy and benefits of the scale-out approach and for comparisons to the traditional “scale-up” manufacturing model click here.

 

Ireland (MFG 6 and 7)

These state-of-the-art “facilities of the future” will utilize the novel “scale-out” manufacturing approach WuXi Biologics has pioneered deploying multiple single-use bioreactors for commercial biomanufacturing and the sites are also designed to run commercial-scale continuous bioprocesses. When completed this facility will represent the world’s largest facility using single-use bioreactors. The manufacturing facilities will reside on a 26-hectare (~52 acre) brown-field site (all utilities currently available) just 45 minutes from Dublin and it is the company’s first site outside of China. Site construction is to start in late 2018 and development of the site is supported by the Irish Government through IDA Ireland.

Site Details

  • Fed-batch Cell Culture: 48,000 L
  • Perfusion Cell Culture: 6 x 1,000 L
  • Additional Drug Product Fill and Finish (see here for more details)
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Shijiazhuang (MFG 8)

The new state-of-the-art biologics center will include process development labs, clinical and commercial manufacturing and built to meet cGMP standards of the United States, the European Union, and China. Besides serving global clients, the new integrated center will also support Marketing Authorization Holder (MAH) system in China and address urgent needs of Chinese partners. Initial phase of the center will be operational in 2020.

Site Details

  • Clinical and Commercial: 48,000 L

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Singapore (MFG 10)

This new manufacturing facility, supported by the Singapore Economic Development Board, will be the Company’s first overseas site in Asia. The state-of-the-art facility will be built upon the novel approach WuXi Biologics has pioneered deploying single-use bioreactors. It is also designed to run continuous bioprocessing, a next generation manufacturing technology, the first to be implemented in Asia outside of China. This facility will be designed to handle both clinical and small-volume commercial production. An early-stage bioprocess development lab will also be included.

Site Details

  • Fed-batch cell culture: 2 x 2,000 L
  • Perfusion cell culture: 500 L (ATF6™)

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Worcester, MA (MFG 11)

This state-of-the-art “facility of the future” will be built upon the novel approach that WuXi Biologics has pioneered in deploying single-use bioreactors. It is also designed to run continuous bioprocessing, a next-generation manufacturing technology. This facility will handle both clinical and small volume commercial production. An early-stage bioprocess development lab will also be included.

Site Details

  • Fed-batch cell culture: 2 x 2,000 L
  • Perfusion cell culture: 500 L (ATF6™)

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Scale-out manufacturing strategies offer greater flexibility, scalability, time and cost savings versus traditional scale-up strategies. Contact us to discuss further or to learn more!

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