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Drug Substance Manufacturing

WuXi Biologics operates multiple world-class GMP manufacturing facilities for the production of biologics. Utilizing mammalian cell culture, we are able to produce a wide variety of biologics including monoclonal and bispecific antibodies, fusion proteins, antibody drug conjugates and other recombinant proteins. Over 90,000L of bioreactor capacity is available (150,000L by the close of 2021) for both clinical trials and commercial drug substance supply, increasing to 430,000L by 2023. 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 “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 200L and 1 x 500 L single-use/disposable bioreactors, and the Wuxi city Pilot Plant maintains 3 x 250L 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.

MFG 1 (Wuxi)


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: 200 L (ATF6™ & ATF10™)
  • 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 formulation and fill

MFG 2 (Wuxi)


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 the world’s largest manufacturing facility utilizing single-use/disposable bioreactor technology (30,000 liters).  The MFG2 site has receive GMP accreditation from the U.S. FDA and NMPA.  This is 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 2,000L
  • GMP Perfusion Cell Culture: 2 x 1,000L (equipped ATF10™)
  • Facility designed by NNE Pharmplan
  • Cost-effective Hybrid Design (uses single-use technology and stainless steel media/buffer preparation systems)

MFG 3 (Shanghai)


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 holds the European Medicines Agency’s (EMA) certified cell banking facilities for our client’s clinical GMP manufacturing drug substance supply. 


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)


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 July 2019. This site is the first GMP facility in China to use the industry’s largest disposable bioreactor (4,000L) and the site was inspected and is certificated by the EMA for GMP manufacturing.


Site Details:

 

  • GMP fed-batch cell culture, 2 x 1,000L, 2 x 2,000L, 1 x 4,000L
  • GMP continuous cell culture with ATF technology, 2 x 1,000L, 2 x 2,000L
  • Uses the industry’s largest single-use bioreactor (4,000L ABEC)
  • Utilizes single-use bioreactors
  • 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)


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, MFG 5 offers batch scale production ranging from 2,000 L to 36,000 L. MFG 5 has a total cell culture capacity of 60,000 L, making it one of the largest single-use bioreactor-based DS facilities in the world. This facility hosts two production lines: the 4k line with 9 x  4,000 L ABEC bioreactors and the 2k line with 12 x 2,000 L GE bioreactors. 

 

 

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


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

MFG 8 (Shijiazhuang)


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

MFG 10 (Singapore)


GMP Available in 2023

 

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, and 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 at the site.


Site Details:

 

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

MFG 11 (Worcester, MA)


GMP 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. An early-stage bioprocess development lab will also be included.


Site Details:

 

  • Fed-batch cell culture: 16,000L
  • Perfusion cell culture: 500L(ATF6™)

MFG 12 (Chengdu)


GMP Available in 2023

 

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)


NBI (New Business Initiative) viral platform can support the integrated CMC development and GMP manufacturing of viral vector based products like gene therapy vectors, oncolytic virus, and vaccines. NBI GMP facility has a 2,000 square meter clean production plant, which is constructed in accordance with BSL-II and cGMP standards. The process production area uses dedicated new wind system and a large number of disposable processes to support multiple product manufacturing simultaneously. The facility will be fully GMP released for use in Q1 2021. The maximum production scale is 2×1000 L, and the annual maximum production capacity can exceed 60 batches.


Site Details:

 

  • One suite of suspension culture lines, including microcarrier based adherent cell culture: 50L – 1000L
  • One suite of adherent cell and virus culture line: Cell Factory, Hyperstack 
  • One flexible purification suite, with extensive utilization of advanced single use technology
  • Robotic aseptic filling isolator for virus DP
  • Extensive flexibility to support complex drug filling processes of biologic therapies

MFG 14 (Hangzhou)


NBI (New Business Initiative) microbial platform can deliver integrated CMC package based on E. coli and yeast fermentation, and achieve from lab grade to GMP grade product need for both plasmids and proteins. Our PD lab has various scale (from 250ml high-throughput mini-fermenter to 3L, 5L and 14L) fermenter, to meet different client needs, and is able to deliver gram-level lab material generation. Our 110M2 HQ/GMP suite could support 10-50L fermentation and downstream purification. GMP manufacture facility has total 2000M2 clean rooms. In Phase I, a 30- 300L single-use scale production line is to be built; in Phase II, stainless steel fermenter production lines with max 2000L USP and DSP capacity will be built. A maximum production capacity of 160 batches per year could be achieved by then. Our process development platform in Hangzhou will be delivered by the end of 2020, and our Phase I GMP facility will be ready by Q2 2021.


Site Details:

  • BSL1 facility, GMP ready by Q2 2021
  • 2,000m2 GMP suites with SUF and SS fermenters
  • Upstream
    • 1 Single-use line with scale up to 300L (July 2021)
    • 3 Stainless steel lines with scale up to 2000L (Q3 2021)
  • Downstream: 3 purification lines 
  • One integrated production line with both upstream and downstream in one ball room
  • One DS fill line

MFG 18 (Cranbury, NJ)


GMP Available in H2 2021

 

This recently acquired 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 will be the first operational bioprocessing site in North America for WuXi Biologics. This site will contain both upstream and downstream process development laboratories and two suites of 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: 200L to 2,000L
  • Up to 6,000L total bioreactor capacity

MFG 19 (Wuppertal)


GMP Available H2 2021

 

This 30,000-square-meter state-of-the-art DS facility (MFG19), was acquired from Bayer in December 2020. The facility will maintain 3 x 1000L perfusion and 6 x 2000L fed-batch capacity with independent downstream 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 2,000L suites
  • GMP Perfusion Cell Culture: 3 x 1,000L 
  • Separate primary and final purification suites (pre- and post-viral)

MFG 20 (Hangzhou)


GMP Available in H2 2021

 

WuXi Biologics acquired the 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 sq. m. facility, GMP operational since 2018, includes DS capacities equipped with 2 x 2000L single-use bioreactors expandable to 4 x 2000L and DP capacities of vial filling (DP9) and pre-filled syringe (DP10). 


Site Details:

 

  • GMP Fed Batch Cell Culture: 2 x 2,000L / expandable to 4 x 2,000L
  • Onsite Drug Product formulation and fill
  • Site has been GMP-ready since 2018

MFG 21 (Suzhou)


GMP Available in H2 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 is building up drug substance facility MFG21, and drug product 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