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Drug Substance (DS) Manufacturing

WuXi Biologics operates multiple world-class GMP manufacturing facilities for the production of biologics around the world. Utilizing mammalian cell culture (e.g., CHO, NS0, HEK), and featuring our industry-leading WuXiaTM cell line development platform, we are able to produce a wide variety of biologics including monoclonal, bispecific and multispecific antibodies, fusion proteins, antibody drug conjugates, enzymes and other recombinant proteins. Over 260,000 L of bioreactor capacity is available by the close of 2022 for both clinical trials and commercial drug substance (DS) supply, increasing to 580,000 L across five countries by 2026. Clinical and commercial scale drug product GMP manufacturing is also available.
 

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. The success of our GMP operations is also due to our concept to commercialization drug development platform and excellence in project execution (see “The WuXi Biologics Difference” short videos for more information).
 

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.
 

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 wastewater 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. Click on the individual tabs below to learn more about each facility.

MFG 1 (Wuxi)


GMP Manufacturing Available Since 2012

 

Designed and constructed based on United States, European Union and Chinese cGMP requirements, WuXi Biologics’ first GMP Drug Substance (DS) manufacturing facility is utilizing only single-use/disposable bioreactors that are 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 MFG 1 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 March 2018; and passed the EMA (European Medicines Agency) Pre-Approval Inspection in March 2019 for the production of a commercial biotherapeutic (both Drug Substance and Drug Product).  Since 2019, this site has passed additional U.S. FDA, EMA and NMPA inspections.


Site Details:

 

  • GMP Perfusion and Concentrated Fed-Batch Cell Culture: Up to 1,000 L (ATF6™ & ATF10™)
  • GMP Fed-Batch Cell Culture: 200 L, 500 L, 1,000 L, 5 x 2,000 L
  • Separate primary and final purification suites (pre- and post-viral)
  • On-site Drug Product formulation and fill

MFG 2 (Wuxi)


GMP Manufacturing Available Since 2017

 

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. It has been operational since 2017 for both large-scale perfusion and fed-batch cell culture manufacturing. The total production capacity of MFG 2 makes this site one of the world’s largest manufacturing facilities utilizing single-use/disposable bioreactor technology (>30,000 liters).  The MFG2 site has passed inspections from multiple global regulatory agencies  including the U.S. FDA, EMA, Health Canada, MFDS, PMDA, ANVISA and NMPA.  This was WuXi Biologics’ first manufacturing facility to utilize a “scale-out” manufacturing approach for large-scale biologics drug substance 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 single-use bioreactors
  • GMP Perfusion Cell Culture: 4 x 1,000 L (equipped with ATF10™)
  • Facility designed by NNE Pharmplan
  • Cost-effective Hybrid Design (uses single-use technology and stainless steel media/buffer preparation systems)

MFG 3 (Shanghai)


GMP Manufacturing Available Since 2018

 

Operations began in April 2018 for the MFG 3 site. This facility is a 200,000 sq. ft. state-of-the-art production plant, currently offering complete biologics development and manufacturing in one central location. This single-source paradigm helps streamline clinical development even further for our clients. The site has passed inspections by the U.S. FDA and NMPA and also holds the European Medicines Agency’s (EMA) certified cell banking facilities we use to manufacture our client’s Master, Working and End of Production cell banks.  

WuXi Biologics developed a new continuous manufacturing process called WuXiUP™, which combines intensified perfusion cell culture and a continuous direct product capture process. This new manufacturing platform has been implemented in MFG 3 for several projects. Additionally, the in-line condition and in-line dilution systems were introduced to the facility to boost the efficiency of production through new buffer preparation automation processes.


Site Details:

 

  • GMP Fed-Batch Cell Culture: 1 x 200L/500L, 1 x 1,000L, 2 x 2,000L
  • GMP Perfusion Cell Culture: 1 x 200L, 1 x 500 L (ATF6™), 1 x 1,000L (ATF10™)
  • Three separate downstream production suites (with pre- and post-viral rooms)
  • The total production capacity of MFG 3 is 7000L and 72 batches per year.
  • 30,000 sq. ft. process development labs
  • Ten GMP cell banking suites and storage

MFG 4 (Wuxi)


GMP Manufacturing Available Since 2019

 

This world-class facility is in close proximity to our other manufacturing sites in Wuxi city. It is the first facility completed as part 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 2019. This site was the first GMP facility in China to use at the time, the industry’s largest disposable bioreactor (4,000L) and the site passed inspections or was certificated by the EMA, ANVISA and WHO for GMP manufacturing.


Site Details:

 

  • GMP fed-batch cell culture, 3 x 2,000L, 1 x 4,000L
  • GMP continuous cell culture with ATF technology, 3 x 2,000L
  • Utilizes single-use bioreactors including one of the industry’s largest single-use bioreactors (4,000L ABEC)
  • Dedicated harvest room with continuous centrifuge and depth filtration
  • Segregated pre-viral and post-viral rooms
  • Bulk drug substance fill in isolator or BSC
  • Media and buffer preparation in disposable systems

MFG 5 (Wuxi)


GMP Manufacturing Available Since 2021

 

The WuXi Biologics’ Manufacturing 5 facility (MFG 5) is one of the world’s largest drug substance facilities using single-use bioreactors. Located in the Mashan district of Wuxi, MFG 5 offers 753,000 sq. ft. of manufacturing, quality control, utilities and warehousing functions.
 

MFG 5 is designed to maximize operational flexibility. With WuXi Biologics’ unique scale-out approach, the MFG 5 site has a total bioreactor capacity of 60,000 L and offers batch scale production ranging from 2,000 L to 36,000 L. This facility hosts two production lines: one with 12 x 2,000 L Cytiva bioreactors for fed batch production and a 2 x 2000 L line using Thermo bioreactors for continuous cell culture (using ATF 10 systems).

 

 

The two production lines allow flexible batch scale manufacture and can match clients’ increasing and various supply needs. 


Site Details:

 

  • Single-use bioreactors only using our “scale-out” biomanufacturing approach
  • GMP fed-batch: 2 x 12,000 L 
  • GMP continuous cell culture with ATF 10 technology, 2 x 2,000 L

MFG 6 & 7 (Ireland)


GMP Manufacturing Available in 2022

 

These state-of-the-art “facilities of the future” will utilize the novel “scale-out” manufacturing approach that WuXi Biologics has pioneered, deploying multiple, single-use bioreactors for commercial biomanufacturing. 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 (~64 acre) site, just 45 minutes from Dublin and one hour from Belfast. 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:

 

  • GMP Fed-batch Cell Culture: Ballroom Design: 12 X 4,000 L
  • GMP Perfusion Cell Culture: 6 x 1,000 L (equipped with ATF10™)<sup< sup=””></sup<>
  • Cost-effective Hybrid Design (uses single-use technology and stainless-steel media/buffer preparation systems)

MFG 8 (Hebei)


GMP Manufacturing Available in 2022

 

The commercial manufacturing facility (MFG 8) with a 48,000 L bioreactor capacity, will be built to meet cGMP standards of the United States, the European Union and China. Besides serving global clients and being one of the largest single-use/disposable manufacturing sites in the world, the new integrated center will also support the Marketing Authorization Holder (MAH) system in China and address urgent needs of Chinese partners.

The MFG 8 site occupies 80,389 m2 and includes manufacturing, administration, warehouse, engineering and waste process facilities. The initial phase of the center will be operational in 2022. 


Site Details:

 

  • 12 x 4,000L Fed-batch, single-use cell culture 
  • Hybrid design composed of stainless-steel media/buffer plus single-use purification systems

MFG9 (Wuxi)


Site Construction by 2026

 

This commercial-scale manufacturing facility (MFG 9) located in Wuxi, China will maintain >100,000 L bioreactor capacity and will be built to meet cGMP standards of the United States, the European Union and China. Besides serving global clients and being one of the largest single-use/disposable equipment manufacturing sites in the world, the new integrated center will also support the Marketing Authorization Holder (MAH) system in China to help address urgent needs of our Chinese clients and patients.

 

The MFG 9 site includes manufacturing, administration, engineering and waste process facilities. The initial phase of the center will be operational in 2026. The site will enable more commercial product production to be conducted for our global partners, create more jobs for local talents and stimulate growth for the biologics industry in Wuxi.


Site Details:

 

  • 100,000 L fed-batch, single-use bioreactors for mammalian cell culture 
  • Utilizes our “scale-out” biomanufacturing approach
  • Hybrid facility design composed of stainless-steel media/buffer preparation systems plus single-use purification unit operations

MFG 10 (Singapore)


GMP Manufacturing Available in 2026

 

This new manufacturing facility, supported by the Singapore Economic Development Board, will be the company’s first CRDMO 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, and the first to be implemented in Asia outside China. This facility will be designed to handle both clinical- and commercial-scale production and will be an integral part of the company’s Global Dual Sourcing strategy for our clients.   Early-stage / R&D labs for the development of a wide-range of biologics will also be included at the site.  GMP manufacture of Drug Product (DP) is also part of the overall site plan.


Site Details:

 

  • Total cell culture bioreactor capacity: 120,000L
  • Drug Product manufacture (formulation and fill)
  • Biologics R&D laboratories

MFG 11 (Worcester, MA)


GMP Manufacturing Available in 2024

 

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 as part of the company’s Global Dual Sourcing strategy for our clients. An early-stage bioprocess development lab will also be included.


Site Details:

 

  • Fed-batch cell culture: 24,000L
  • Perfusion cell culture: 500L(ATF6™)

MFG 12 (Chengdu)


GMP Manufacturing Available in 2025

 

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


Site Details:

 

  • Biologics research and development services
  • Two suites of 6 x 4,000L fed-batch, single-use cell culture
  • Hybrid design composed of stainless-steel media/buffer plus single-use purification systems

MFG 13 (Hangzhou)


GMP Manufacturing Available Since 2021

This integrated CMC development and GMP manufacturing site has a 2,000 m2 production plant, which is constructed in accordance with BSL-II and cGMP standards.  The facility was released for GMP production in Q1 2021. The maximum production scale is 2 x 1,000 L, and the annual maximum production capacity can exceed 60 batches.


Site Details:

 

  • Up to 2 x 1,000 L bioreactor capacity
  • One flexible purification suite, with extensive utilization of advanced single use technology
  • Robotic aseptic filling isolator for Drug Product formulation and fill
  • Extensive flexibility to support complex biotherapeutic filling processes

MFG 14 (Hangzhou)


GMP Manufacturing Available Since 2021

 

This site is designed to deliver integrated CMC development and manufacturing for biologics and vaccines produced from microbial fermentation (e.g.,  E. coli and yeast).  This site offers extensive flexibility for the production of lab- to GMP grade plasmids, proteins, virus like particles (VLPs) and RNA. Our PD lab offers various production scales (from 250 ml high-throughput mini-fermenters to 3, 5 and 14 L fermenters), to meet our clients differing research material needs. Our 110m2 High Quality (HQ) / GMP suite provides 10, 30, 50, 300 and 2,000 L fermenters. The BSL-1 GMP manufacturing facility has 2,000 m2 of clean rooms.  A maximum production capacity of 160 batches per year could be achieved in this facility. 


Site Details:

  • BSL1 facility with 2,000m2 GMP suites
  • Single-use and stainless steel fermenters
  • Upstream: 3 suites
    • 1 Single-use fermenter line with scale up to 300 L 
    • 1 Stainless steel fermenter line with scale up to 500 L 
    • 1 Stainless steel fermenter line with scale up to 2,000 L 
  • Downstream: 3 purification lines 
  • One multi-purpose integrated production line (110 m2) with both upstream and downstream areas in one ball room offering 10 – 50 L fermenters
  • One DS fill line

MFG 17 (Shanghai)


GMP Manufacturing Available in 2023

 

This 1.6 million sq. ft. global innovation site located in the Fengxian district of Shanghai, will be a fully-integrated biologics discovery, development and GMP manufacturing center providing our clients a true one-stop concept to commercialization biotherapeutics development solution.


Site Details:

  • Fed-batch cell culture capacity: 10,000 L
  • Discovery R&D, process and analytical development and QC laboratories available on-site

MFG 18 (Cranbury, NJ)


GMP Manufacturing Available Since 2021

 

This 66,000 sq. ft. site in Cranbury, New Jersey, is located in a business park near other biotech companies such as Amicus and WuXi AppTec. It is the first operational bioprocessing site in North America for WuXi Biologics. This site will contain both upstream and downstream process development laboratories and two GMP manufacturing suites using single-use bioreactors for clinical trial drug substance production. State-of-the-art analytical development and Quality Control (QC) labs for lot release and stability will also be available.


Site Details:

 

  • Fed-batch cell culture: 200 L to 2,000 L
  • Up to 6,000 L total bioreactor capacity
  • Development and QC labs 

MFG 19 (Wuppertal)


GMP Manufacturing Available Since 2021

 

This 30,000 m² state-of-the-art DS facility (MFG19), was acquired from Bayer in December 2020. The facility  provides 12,000 L bioreactor capacity and can perform both fed-batch and perfusion cell culture.  The site maintains independent downstream / purification suites. The site will further enhance WuXi Biologics’ Global Dual Source network for supply of vaccines and other biologics. Together with the Drug Product facility in Leverkusen (DP7), this new DS facility will be used for commercial manufacturing, allowing WuXi Biologics to meet clients’ increasing demand for outsourced manufacturing services. 


Site Details:

 

  • GMP Fed-Batch Cell Culture: 6 x 2,000 L suite
  • GMP Perfusion Cell Culture Available: 3 x 2,000 L
  • Separate primary and final purification suites (pre- and post-viral)
  • Integrated development labs and warehousing on-site

MFG 20 (Hangzhou)


GMP Manufacturing Available Since 2021

 

WuXi Biologics acquired this state-of-the-art biologics manufacturing facility as well as its labor force from Pfizer China (“Pfizer”) in March 2021. This site immediately boosted the commercial Drug Substance (DS) and Drug Product (DP) capacities for WuXi Biologics to address surging manufacturing demands. The 50,000 m² facility, GMP operational since 2018, includes DS capacities equipped with 4 x 2,000 L single-use bioreactors expandable to 32,000 L in 2023 and Drug Product (DP) manufacturing (formulation and fill) of vials (DP9) and pre-filled syringes (DP10)


Site Details:

 

  • GMP Fed Batch Cell Culture: up to 4 x 2,000 L (expandable to 32,000 L in 2023)
  • Onsite DP formulation and fill
  • Site has been GMP-ready since 2018 and began GMP production at WuXi Biologics in Quarter 2, 2021

MFG 21 (Suzhou)


GMP Manufacturing Available Since 2021

WuXi Biologics acquired CMAB Biopharma Group in 2021, and renamed it as WuXi Biologics (Suzhou) as a wholly owned subsidiary of the company. With the acquisition, WuXi Biologics gained this drug substance facility (MFG21), that also includes a drug product manufacturing facility (DP11) for liquid and lyophilization, to help expand the company’s global DS and DP capacity.


Site Details:

 

  • GMP Fed-Batch Cell Culture: 7,000L
  • Process development laboratories
  • Liquid and Lyophilization Drug Product Fills

 

Click here to see a 360° virtual tour example of some of our GMP downstream purification suites