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 WuXi Biologics Headquarters in Shanghai (2021 Construction) | |
| Company type | Public |
|---|---|
| SEHK: 2269 Hang Seng Index Component | |
| ISIN | KYG970081173 |
| Industry | |
| Founded | 2015; 10 years ago (2015) inWu Xi City, China |
| Headquarters | Primary: 108 Meiliang Road, Mashan, Binhu District, Wuxi, Jiangsu, China, 214092 |
Area served | Worldwide |
Key people |
|
| Parent | WuXi AppTec |
| Subsidiaries | WuXi Vaccines CMAB Biopharma Group |
| Website | www |
| Footnotes / references [1][2][3][4] | |
WuXi Biologics is a global Contract Research Development and Manufacturing Organization (CRDMO) that provides open-access, integrated technology platforms forbiologics drug development.
WuXi Biologics' roots date back to 2010, and began building out capabilities and facilities required for biologics discovery, development and good manufacturing practices (GMP).[5] WuXi Biologics went public on the Hong Kong Stock Exchange in June 2017.[6]
As of 2021, WuXi Biologics has 18 manufacturing sites including ten in China, three in the United States, two in Ireland, two in Germany, and one in Singapore.[7]
In August 2020, WuXi Biologics was selected to become a component of theHang Seng Index in Hong Kong.[8]
In January 2024, WuXi Biologics' share price fell on news that theUnited States Congress had introduced legislation to block any federal government contracts with the company due to national security concerns.[9][10][11] The concerns stem from allegations, denied by the company, that it has worked closely with thePeople's Liberation Army as a part of theChinese Communist Party'smilitary-civil fusion strategy.[12] Members of theUnited States House Select Committee on Strategic Competition between the United States and the Chinese Communist Party subsequently called for sanctions against WuXi Biologics.[13]
WuXi Biologics has two sites in Shanghai, one in theShanghai Waigaoqiao Free Trade Zone and the other inFengxian.[citation needed]
WuXi Biologics has two sites located inWu Xi City, China. TheMashan site contains MFG1, MFG2, MFG4 and MFG5.[14] and theWuxi 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.[15][16]
As of March 2021, WuXi Biologics will have two sites in Hangzhou China.
On March 17, 2021, WuXi Biologics announced an equity agreement withPfizer China to acquire its newly built $350 millionHangzhou 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.[17] Opened in 2020 and slated to be GMP-ready in 2021, theHangzhou 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.[15]
As of March 2021, WuXi Biologics will have two sites located in the city ofSuzhou, China.
On March 18, 2021, WuXi Biologics announced a purchase agreement withCBC 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.[18] 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.[15]
Currently slated to open in 2023, theChengdu 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 bulkactive pharmaceutical ingredient (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.[15][19]
Currently slated to open in 2022, theShijiazhuang 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.[15]
On May 24, 2018, WuXi Biologics announced it will be building a $60 million facility (MFG10) inSingapore 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.[15] The project is backed by theSingapore Economic Development Board and will be dedicated to clinical and small volume commercial production as well as early-stage bioprocess development.[20]
On January 17, 2020, WuXi Biologics andBayer 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 inLeverkusen, 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'sKovaltry anti-hemophilic infusions which are primarily finished in another plant in Berkeley, California.[21]
On December 21, 2020, WuXi Biologics and Bayer announced a new acquisition agreement for a drug substance (DS) production site for €150 million inWuppertal, Germany.[22]
In April 2018,[23] 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 throughIDA 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.[24] 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.[25]
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.[26]
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 inWorcester, 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.[27]
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) inCranbury, 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.[28]
In May 2020, WuXi Biologics announced it had leased a 33,000 sq ft (3,100 m2) process development lab inKing of Prussia, Pennsylvania atDiscovery Labs, a formerGlaxoSmithKline manufacturing site.[29]
