Custom Protein Generation

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Antibody Drug Conjugates

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WuXi Biologics is the first biologics company in
China approved by both the U.S. FDA and EMA
WuXi Biologics to Invest S$80 Million to Establish
a Biologics Manufacturing Facility in Singapore
WuXi Biologics Commenced Construction of the Largest
Biomanufacturing Facility Using Single-Use Bioreactors in Ireland
WuXi Biologics to Install Industry’s Largest Single-Use Bioreactor
from ABEC at its New Commercial Manufacturing Facility
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WuXi Biologics operates multiple world-class GMP manufacturing facilities for the production of biologics (monoclonal and bispecific antibodies, fusion proteins, antibody drug conjugates and other recombinant proteins) utilizing mammalian cell culture. Over 54,000 L of bioreactor capacity is available for both clinical trials and commercial drug substance supply, growing to 280,000 L by 2022. Clinical-and-commercial-scale drug product GMP manufacturing 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 support scale-up development efforts and large-scale process or batch record verification/qualification activities both Wuxi and Shanghai maintain pilot / non-GMP manufacturing facilities.  The manufacturing runs conducted at these sites also provide drug supply for IND-enabling toxicology studies or other preclinical and CMC development activities.  The Shanghai Pilot Plant capacity is 6 x 200 L and 1 x 500 L single-use/disposable bioreactors and the Wuxi city Pilot Plant maintains 3 x 250 L single-use/disposable bioreactors.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 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 award at the Facility of the Year Awards in 2014 by the International Society for Pharmaceutical Engineering (ISPE). The MFG1 facility obtained a “Drug Production License” issued by NMPA (China National Medical Products Administration) in September 2016, passed the U.S. FDA Pre-License Inspection in September 2017 and the EMA (European Medicines Agency) Pre-Approval Inspection in February 2019 for the production of a commercial biotherapeutic (both Drug Substance and Drug Product – see press release).

 

Site Details

  • GMP Perfusion Cell Culture: 2 x 200 L (ATF6™)
  • GMP Fed-Batch Cell Culture: 200 L, 500 L, 1,000 L, 3 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 compliant with global GMP standards has been operational since 2016 for both large-scale perfusion and fed-batch cell culture manufacturing. As of the year 2018 this site was the world’s largest manufacturing facility using single-use/disposable bioreactor technology. It’s WuXi Biologics’ first manufacturing facility 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

  • GMP Fed Batch Cell Culture: 2 suites, each with 7 x 2,000 L
  • GMP 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

To learn more about our approach, see our WuXiUP technology platform page, an industry led Q&A session or our on-demand webinar 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 manufacturing in one central location thus streamlining clinical development even further for our clients.

Site Details

  • GMP Fed-Batch Cell Culture: 1 x 200 L, 1 x 500 L, 1 x 1,000 L, 2 x 2,000 L
  • GMP 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
  • Ten GMP cell banking suites and storage

 

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Wuxi city (MFG 4)

This world-class facility is in close proximity to our other manufacturing sites in Wuxi city. It is the first facility completed of a larger biotech hub/campus that will also feature new discovery, development and commercial-scale manufacturing. The manufacturing suites have been GMP-ready since July 2019.

Site Details

  • GMP Fed-Batch Cell Culture, 2 x 1,000 L, 2 x 2,000 L, 1 x 4,000 L
  • Uses the Industry’s largest single-use / disposable bioreactor (4,000 L ABEC)
  • Utilizes all single-use/disposable bioreactors
  • Dedicated harvest room with centrifuge and depth filtration
  • Segregated pre-viral and post viral rooms
  • Bulk drug substance fill conducted in isolator
  • Media and buffer preparation in disposable systems as well
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Wuxi city (MFG 5 & 9) – GMP Available 2020/2021

These purpose-built world-class facilities will be part of a 4 million sq. ft. biotech hub/campus housing new discovery, development, clinical and commercial GMP manufacturing capacities. This site is in close proximity to our other sites in Wuxi city. Commercial manufacturing is expected to come on-line in 2020 with additional clinical-scale GMP manufacturing to be available in 2021.

Site Details

  • Fed-Batch Cell Culture:
    • 10,000 L (Clinical Production-MFG 9)
    • 60,000 L (Initial Commercial Production-MFG 5)
    • Over 200,000 L total planned bioreactor capacity (all single-use/disposable systems)
  • 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 & 7) – GMP Available 2021

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 bioprocessing. When completed this facility will represent one of the world’s largest facilities 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 began 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 city (MFG 8) – GMP Available 2021

The new state-of-the-art biologics center will include process development labs, clinical and commercial manufacturing and is 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) – GMP Available 2021

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 of single-use bioreactors that WuXi Biologics has pioneered. It is also designed to run continuous bioprocessing, a next generation manufacturing technology, the first to be implemented in Asia outside 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, USA (MFG 11) – GMP Available 2022

This state-of-the-art “facility of the future” will be built upon the novel approach of single-use bioreactors that WuXi Biologics has pioneered. 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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Chengdu city (MFG 12) – GMP Available 2022

This new 1.3 million sq. ft. center will include integrated drug development and clinical and commercial manufacturing facilities.  The new site will enable more projects to be conducted for our global partners, while creating more jobs for local talents and stimulating growth for the biologics industry in Chengdu as well as the entire biologics ecosystem in Southwest China.

Site Details

  • Biologics research and development services
  • 48,000 L (12 x 4,000 L) bioreactor capacity 

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Summary of Current Drug Substance Global Capacity

Site DS Bioreactor Capacity GMP Ready Location Comments
MFG 1 7,700 L fed-batch/ 400 L perfusion 2012 Wuxi, China Clinical/Commercial

(Approved by the U.S. FDA and EMA)

MFG 2 28,000 L fed-batch / 2,000 L perfusion 2017 Wuxi, China Commercial
MFG 3 5,200 L fed-batch / 1,500 L perfusion 2018 Shanghai, China Clinical/Commercial
MFG 4 10,000 L fed-batch/Concentrated Fed-Batch (CFB) 2019 Wuxi, China Clinical/Commercial

 

 

Summary of Future Planned Expansion of Drug Substance Global Capacity

Site DS Bioreactor Capacity GMP Ready Location Comments
MFG 5 60,000 L fed-batch 2020 Wuxi, China Commercial
MFG 6 6,000 L (6 x 1,000 L) perfusion 2021 Dundalk, Ireland Commercial
MFG 7 48,000 L fed-batch 2021 Dundalk, Ireland Commercial
MFG 8 48,000 L fed-batch 2021 Shijiazhuang, China Commercial
MFG 9 10,000 L fed-batch/CFB 2021 Wuxi, China Clinical/Commercial
MFG 10 4,000 L fed-batch / 500 L perfusion 2021 Singapore Clinical/Commercial
MFG 11 4,000 L fed-batch / 500 L perfusion 2022 Worcester, MA (USA) Clinical/Commercial
MFG 12 48,000 L (12 x 4,000 L) fed-batch 2022 Chengdu, China Clinical/Commercial

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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