WuXi Biologics
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Supported by the Irish Government and IDA Ireland, construction of the manufacturing facilities began in 2018 with operations commencing in 2021
Located in Dundalk, Co. Louth, mid-way between Dublin and Belfast, this 26-hectare site is less than an hour’s drive from Ireland’s two largest cities
This “Factory of the Future” will create 400 jobs and provide commercial biologics manufacturing services
The site is adjacent to the WuXi Biologics “Factory of the Future”
Capabilities at the site will include drug substance and drug product manufacture and quality control
QC potency lab received GMP certificate in 2022 from the Ireland Health Products Regulatory Authority
Over 13,000 sq. m. drug product fill & finish facility (DP7)
Liquid and lyophilization annual fill capacity of 10 million doses
Acquired from Bayer in April 2020 and released for GMP manufacturing in the same year
30,000 sq. m. drug substance manufacturing facility (MFG19)
38 km (30 minutes driving) from the WuXi Biologics drug product fill & finish facility in Leverkusen (DP7) – both sites will support WuXi Biologics’ “Global Dual Source” strategy
Acquired from Bayer in May 2021
Over 189,500 sq. ft. drug substance manufacturing facility (MFG11) featuring state-of-the-art single-use technology located within The Reactory biomanufacturing park in Worcester, MA
Dedicated to biologics clinical- and commercial-scale drug substance cGMP manufacturing with total bioreactor capacity of 24,000L
Construction completed and operations to commence in 2024
Over 154,400 sq. ft. of laboratories and manufacturing suites located in the robust biopharmaceutical tristate region of NY, NJ and PA
Services include biologics CMC development and clinical-scale drug substance and drug product cGMP manufacturing
Site operations commenced in 2021
Drug substance manufacturing facility (MFG18) GMP release in 2022
Robotic drug product fill and cGMP manufacturing facility (DP12) operations and GMP release expected in 2024
More than 33,000 sq. ft. facility located in the Discovery Labs campus in King of Prussia (KOP), PA
Services include biologics process development and process characterization
Biosafety Level 2 laboratories
Operational since 2020
The site offers comprehensive, integrated one-stop biologics discovery, development and clinical manufacturing services in one central location
European Medicines Agency (EMA)-certified GMP cell banking suites
200,000 sq. ft. clinical drug substance manufacturing facility (MFG3) has been operational since 2018
1.6 million sq. ft. Integrated Biologics CRDMO center
The Center provides biologics discovery, development and clinical GMP manufacturing services in one location
Operational since 2021
Drug substance manufacturing facility (MFG17) and drug product fill & finish facilities (DP14 and DP15) are expected to be GMP released in 2023
8,000 sq. m. Biosafety Testing Center
Capabilities include cell bank characterization, unprocessed bulk harvest, virus harvest, and raw materials of animal origin release testing as well as viral clearance studies
Operational since 2022
Multiple drug substance and drug product manufacturing facilities (MFG1, MFG2, MFG4, MFG5, DP1, DP2, DP4, DP5) located in this region with a total facility footprint of 160,000 sq. m.
Capabilities include early and late-stage process development and clinical & commercial-scale drug substance and drug product GMP manufacturing
First biologics facility in China approved by the U.S. FDA and EMA for commercial manufacturing
6,000 sq. m. site dedicated to the development and GMP manufacturing of Antibody Drug Conjugates (ADCs) and other bioconjugates.
Capabilities include process development, pilot scale to large-scale cGMP manufacturing of drug substance and drug product.
GMP release of this facility commenced in 2019
Over 16,000 sq. m. Biosafety Testing Center, one of the first third-party centers for biosafety testing services in Asia
Services include cell line characterization and adventitious agent testing for the QC release of cell banks, unprocessed bulk (UPB) lots and raw materials as well as viral clearance per global regulatory guidelines.
Operational since 2014
Site contains a drug substance manufacturing facility (MFG21) and drug product fill & finish facility (DP11)
Services include process development, clinical drug substance manufacturing as well as liquid and lyophilization drug product fills
Site acquired from CMAB Biopharma Group and released for GMP manufacturing in 2021
35,000 sq. m. Biologics Integrated Innovation Center
The center serves the development and GMP manufacturing of microbial-derived products and mRNA products
Operational since 2020
The site includes drug substance manufacturing facility (MFG14) and drug product fill & finish facility (DP8), which were released for GMP manufacturing in 2022
50,400 sq. m. manufacturing site that includes a drug substance manufacturing facility (MFG20) and drug product fill & finish facilities (DP9 and DP10)
Facilities acquired from Pfizer China and were released for GMP manufacturing in 2021
314,000 sq. m. site, WuXi Biologics’ largest site in Southwest China
The Protein Science labs at this site were launched in November 2022
The initial bioreactor capacity of 48,000L for drug substance GMP manufacturing is expected to be available in 2024
82,160 sq. m. site, one of the largest biologics CDMO sites in northern China
The site flexibly provides commercial manufacturing services at 4,000L to 20,000L scale
Drug substance manufacturing facility (MFG8) GMP release commenced in 2022
USD$1.4 billion investment over ten years to build a comprehensive CRDMO Center
The Center will provide end-to-end services from biologics research and development to large-scale drug substance and drug product GMP manufacturing
120,000 liters biomanufacturing capacity is expected to be available in 2026
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