WuXi Biologicsbiopharmaceutical manufacturingbioreactor capacityGMP manufactureAPI production

WuXi Biologics Asia Facilities and Manufacturing Infrastructure

WuXi Biologics Asia Facilities and Manufacturing Infrastructure

WuXi Biologics has established a comprehensive network of state-of-the-art facilities across Asia to support the development and production of complex biologics. By integrating research and development (R&D) with large-scale commercial manufacturing, the company provides critical infrastructure for the global biotechnology sector.

Key Facts

  • Broad Geographic Reach: Operations span multiple Chinese cities including Shanghai, Wuxi, Hangzhou, Suzhou, Chengdu, and Shijiazhuang, as well as an international presence in Singapore.
  • Diverse Capabilities: Facilities specialize in antibody drug conjugates, recombinant proteins, plasmid DNA, and viral-based vaccines.
  • Significant Scale: New sites in Chengdu and Shijiazhuang are designed with initial bioreactor capacities of 48,000 liters each.
  • Specialized Testing: The Suzhou site hosts Asia's first non-governmentally affiliated biosafety testing facility.

Manufacturing Hubs in China

Shanghai and Wuxi

In Shanghai, WuXi Biologics operates two distinct sites located in the Fengxian district and the Shanghai Waigaoqiao Free Trade Zone. In Wuxi City, the company also maintains two sites. The Mashan site houses manufacturing units MFG1, MFG2, MFG4, and MFG5, while the Wuxi New Area site features specialized laboratories dedicated to the production and development of antibody drug conjugates (ADCs), which are targeted therapies combining an antibody with a potent drug.

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Hangzhou

As of March 2021, the Hangzhou presence consists of two sites. This includes MFG13, which focuses on the development and GMP manufacture (Good Manufacturing Practice, a system for ensuring products are consistently produced according to quality standards) of plasmid DNA and recombinant proteins via microbial fermentation, as well as viral-based vaccine production. Additionally, WuXi Biologics entered an equity agreement with Pfizer China to acquire the $350 million Hangzhou global biotechnology center (MFG20), which opened in 2020.

Suzhou

The Suzhou operations include a specialized biosafety testing facility opened in 2014, covering 108,716 sq ft. This site is notable for being the first non-governmentally affiliated biosafety facility in Asia, performing viral clearance validation, cell line characterization, and unprocessed bulk lot release. Furthermore, through an agreement with CBC Group to acquire a majority interest in CMAB Biopharma Group, WuXi Biologics added the MFG21 facility, which provides a 7,000L bioreactor capacity and associated liquid and lyophilization (freeze-drying) fill and finish lines (DP21).

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Chengdu and Shijiazhuang

The company is expanding its Active Pharmaceutical Ingredient (API) production—the raw materials used to create a finished drug—with two major upcoming sites. The Shijiazhuang facility (MFG8), slated for 2022, spans 884,363 sq ft with an initial 48,000-liter bioreactor capacity. The Chengdu facility (MFG12), slated for 2023, will cover 1.3 million sq ft, offering 48,000 liters for commercial production and 5,000 liters for clinical production.

International Expansion: Singapore

Expanding its footprint beyond China, WuXi Biologics announced a $60 million investment in May 2018 to build the MFG10 facility in Singapore. Scheduled to open in 2023, this site will feature an initial bioreactor capacity of 4,500 liters, utilizing two 2,000-liter fed-batch reactors and one 500-liter continuous processing perfusion reactor.

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Facility Summary Table

Overview of WuXi Biologics Asian Facilities
Location Site/Unit Primary Focus / Capacity Status/Year
Wuxi Mashan & New Area MFG1, 2, 4, 5; ADC Development Operational
Hangzhou MFG13 & MFG20 Recombinant proteins, plasmid DNA, vaccines Operational (2021)
Suzhou MFG21 & Biosafety Site 7,000L capacity; Biosafety testing Operational
Shijiazhuang MFG8 API Manufacturing (48,000L) Slated 2022
Chengdu MFG12 API Manufacturing (48,000L Commercial) Slated 2023
Singapore MFG10 4,500L capacity (Fed-batch & Perfusion) Slated 2023

Frequently Asked Questions

What is the purpose of the biosafety facility in Suzhou?

The Suzhou biosafety facility performs critical quality and safety checks, including cell line characterization, viral clearance validation studies, and unprocessed bulk lot release.

What are the capacities of the new Chengdu and Shijiazhuang sites?

Both the Chengdu (MFG12) and Shijiazhuang (MFG8) facilities are designed with an initial commercial bioreactor capacity of 48,000 liters.

What specialized products are manufactured in Hangzhou?

The Hangzhou site (MFG13) is dedicated to the development and GMP manufacture of recombinant proteins, plasmid DNA produced via microbial fermentation, and viral-based vaccines.

What technology is being used at the Singapore facility?

The Singapore MFG10 facility will utilize a mix of two 2,000-liter fed-batch reactors and one 500-liter continuous processing perfusion reactor.

How did WuXi Biologics expand its presence in Suzhou?

WuXi Biologics expanded in Suzhou by acquiring over a 90% interest in CMAB Biopharma Group, which included the MFG21 manufacturing facility and DP21 fill and finish lines.

References

  1. "Leadership". WuXi Biologics. Archived from the original on 2020-12-02. Retrieved 2020-12-06.
  2. "Annual Financial Reports". WuXi Biologics. Archived from the original on 2020-12-02. Retrieved 2020-12-06.
  3. "WuXi Vaccines Overviewlanguage=en-US". Archived from the original on 2020-12-03. Retrieved 2020-12-06.
  4. "WuXi Biologics to acquire CMAB Biopharma Grouplanguage=en-US". Retrieved 2021-03-18.
  5. "CHNA ETF Video Series: WuXi Biologics". loncarfunds.com. Archived from the original on 2019-08-14. Retrieved 2019-08-14.