WuXi Biologics

WuXi Biologics has two sites in Shanghai, China.

• Waigaoqiao Free Trade Zone
  • Facility encompassing 200,000 sq. ft., has been operational since 2018.
  • Site offers comprehensive, integrated one-stop biologics CMC development and GMP manufacturing services in one central location.
  • Facility houses 10 European Medicines Agency (EMA)-certified GMP cell banking suites.
• Fengxian District
  • 1.6 million sq. ft. global innovation site to be operational in 2021
  • New facilities providing discovery, development, analytical development and QC testing and pilot and clinical-scale GMP manufacturing capabilities in one location

WuXi Biologics has two sites located in Wu Xi City, China. The Mashan site contains MFG1, MFG2, MFG4 and MFG5.[10] and the Wuxi New Area site contains labs dedicated to the antibody drug conjugate development and production. With 30,000 liters of capacity, MFG2 was the world's largest single-use bioreactor production facility which was replaced in that metric by MFG5 which has a 60,000 liter capacity and opened on February 9, 2021.[11][12]

As of March 2021, WuXi Biologics will have two sites in Hangzhou China.

On March 17, 2021, WuXi Biologics announced an equity agreement with Pfizer China to acquire its newly built $350 million Hangzhou global biotechnology center site and facilities (MFG20). Expected to close in the first half of 2021, the deal includes the 50,000 m² (540,000 sq ft) of facilities which have been GMP operational since 2018 and are equipped with 2X2000L single-use bioreactors with the ability to expand up to 4X2000L single-use bioreactors. Also included in the acquisition are vial filling (DP9) and pre-filled syringe (DP10) fill and finish lines.[13] Opened in 2020 and slated to be GMP-ready in 2021, the Hangzhou site (MFG13) is home to facilities dedicated to the development and GMP manufacture of recombinant proteins and plasmid DNA produced via microbial fermentation along with separate facilities for the development and production of a viral-based vaccine.[11]

As of March 2021, WuXi Biologics will have two sites located in the city of Suzhou, China.

On March 18, 2021, WuXi Biologics announced a purchase agreement with CBC Group which will allow it to acquire over a 90% interest in CMAB Biopharma Group. The transaction is expected to close in the second quarter of 2021. Along with the controlling stake, WuXi Biologics will also acquire a 7000L bioreactor capacity manufacturing facility (MFG21) in Suzhou and associated liquid and lyophilization (DP21) fill and finish production lines.[14] A second site, opened in 2014 is 108,716 sq ft (10,100.0 m²) and was the first non-governmentally affiliated biosafety testing facility in Asia. The facility performs cell line characterization, viral clearance validation studies, and unprocessed bulk lot release.[11]

Currently slated to open in 2023, the Chengdu facility (MFG12) will be a 1.3×10^⁶ sq ft (120×10^³ m²), with an integrated manufacturing center for innovative biologics and dedicated to R&D and commercial-scale bulk API production with an initial bioreactor capacity of 48,000 liters (11,000 imp gal; 13,000 U.S. gal) for commercial production and 5,000 liters (1,100 imp gal; 1,300 U.S. gal) for clinical production.[11][15]

Currently slated to open in 2022, the Shijiazhuang facility MFG8 will be 884,363 sq ft (82,160.0 m²) and dedicated to development and API manufacturing with an initial bioreactor capacity of 48,000 liters.[11]

On May 24, 2018, WuXi Biologics announced it will be building a $60 million facility (MFG10) in Singapore which will feature an initial bioreactor capacity of 4,500 liters made up of two 2,000 liter fed-batch reactors and one 500 liter continuous processing perfusion reactor to open in 2023.[11] The project is backed by the Singapore Economic Development Board and will be dedicated to clinical and small volume commercial production as well as early-stage bioprocess development.[16]

On January 17, 2020, WuXi Biologics and Bayer announced an acquisition agreement in which WuXi Biologics would take over the operations and lease a 139,931 sq ft (13,000.0 m²) fill site in Leverkusen, Germany. Based on the agreement, the site would perform the final fill-finish of various biologics products produced by WuXi's API sites, and act as a backup for filling operations for Bayer's Kovaltry anti-hemophilic infusions which are primarily finished in another plant in Berkeley, California.[17]

On December 21, 2020, WuXi Biologics and Bayer announced a new acquisition agreement for a 22,917 sq ft (2,129.1 m²) drug substance (DS) production site for €150 million in Wuppertal, Germany. The DS facility, to be called MFG19, will be capable of continuous bioprocessing in a 3X1000L perfusion bioreactor configuration and 6X2000L in a fed batch traditional bioprocessing configuration.[18] Previously used to produce Bayer's Kovaltry anti-hemophilic infusions, the facility will be reconfigured to incorporate single-use technology and would create 300 jobs in the region.[19]

In April 2018,[20] WuXi Biologics announced plans to build a new biologics drug substance manufacturing facility on 26 hectares (64 acres) in Dundalk, Ireland. The project is directly supported by the Irish Government through IDA Ireland, with a cost of approximately $394 million. When completed, the facility will be one of the world's largest plants supporting single-use bioreactors and will help accelerate the development of biologic drugs in Europe.[21] MFG6 will have a perfusion bioreactor capacity of 6,000 liters in a continuous bioprocessing configuration and MFG7 will have a 48,000 liter bioreactor capacity in a traditional fed-batch configuration.[22]

In November 2019, WuXi Vaccines, a subsidiary of WuXi Biologics, announced that it would invest an additional $240 million to build a new 167,056 sq ft (15,520.0 m²) vaccine manufacturing facility at the Dundalk, Ireland site. The vaccine site planned includes drug substance manufacturing facilities, drug product manufacturing, Manufacturing Science and Technology Labs as well as Quality Control labs. In February 2020, WuXi Vaccines announced it had signed a 20-year, $3 billion contract with an unidentified "global vaccine leader" to produce one of the unidentified company's vaccine products at the new facility.[23]

In May 2020, WuXi Biologics announced that it had secured a deal with the Worcester Business Development Corporation at The Reactory, a master-planned manufacturing hub project in Worcester, Massachusetts. The two-story, 107,000 sq ft (9,900 m²) facility will cost $60 million and will employ 150 when it is completed in 2022. The Worcester City Council granted a 20-year, $11.5 million tax increment financing plan to help seal the deal. The new facility will have 16,000 liters of bioreactor capacity, which will include four 4,000-liter traditional fed-batch units and one 500-liter perfusion-based continuous processing unit and will be named MFG11.[24]

In June 2020, WuXi Biologics announced that it had signed a ten-year lease for a 66,000 sq ft (6,100 m²) clinical manufacturing facility (MFG18) in Cranbury, NJ. The facility had previously been leased by Outlook Therapeutics and will install a total of 6,000 liters (1,300 imp gal; 1,600 U.S. gal) of bioreactor capacity, process development, and quality control labs, along with supporting functions.[25]

In May 2020, WuXi Biologics announced it had leased a 33,000 sq ft (3,100 m²) process development lab in King of Prussia, Pennsylvania at Discovery Labs, a former GlaxoSmithKline manufacturing site.[26]