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Offering End-to-End Solutions
WuXi Biologics operates multiple state-of-the-art, world-class drug product (DP) manufacturing facilities for the formulation and fill of biotherapeutics and vaccines as well as liquid or lyophilized parenterals. All of our facilities provide fully-automated final drug product formulation and filling under the Current Good Manufacturing Practice (cGMP) conditions as defined by the worldwide regulatory agencies, including the United States Food and Drug Administration (U.S. FDA), European Medicines Agency (EMA) and National Medical Products Association (NMPA). We have also provided cGMP drug product for clinical trials in other countries such as Japan, South Korea, Singapore, Australia, Israel and India. To see details on each facility, click the corresponding links below.
In operation since 2012 and designed and constructed based on United States, European Union and Chinese cGMP requirements, this site is co-located within the 220,000sq. ft. MFG1 site. The site received an Honorable Mention award at the Facility of the Year Awards in 2014 by the International Society for Pharmaceutical Engineering (ISPE) and 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.
Available for GMP Production in H2 2021
A state-of-the-art Drug Product manufacturing facility equipped with one isolator-based IMA integrated filling line and two 20m2 IMA lyophilizers for sterile vial products with filling volume from 2R to 50R and an annual capacity of up to 10million vials.
Additional equipment includes:
WuXi Biologics only utilizes the highest-qualified containers, closures and raw materials provided by the world’s leading suppliers.
In operation since 2019, this facility is dedicated to providing integrated solutions from concept to commercialization for bioconjugates including Antibody Drug Conjugates (ADCs) and other proteins conjugated to OEB 3, 4 or 5 (or Safebridge II, III or IV) compounds. The site, operated and owned by WuXi XDC, a WuXi Biologics subsidiary, features an OEB5 Isolator for weighing and dissolution of linker-payload or toxins. All product contact surfaces will utilize single-use components or systems to minimize cross-contamination risk throughout the manufacturing process. It can also provide GMP production services including filling and lyophilization for small molecule drugs such as high-potent compounds and cytotoxic compounds, which can meet the requirements for the clinical phases I, II, III and commercial production. The company holds a Drug Manufacturing License issued by China NMPA and also meets U.S. FDA and EMA GMP regulations and EHS requirements.
This state-of-the-art GMP manufacturing facility is equipped with the Vanrx Pharma systems SA25 single-operator, fully-automated, robotic and gloveless isolator capable of filling an annual capacity of five million vials or Pre-Filled Syringes (PFS). This modular “work cell” approach greatly reduces risk due to its minimal human intervention and use of sterile, single-use disposable elements throughout the entire filling operation. This isolator is within a Grade C environment and can achieve as low as ISO 2 level particle counts. The facility has been GMP-ready since July 2019 after successfully completing three media-fill batches. The site received a GMP conformity assessment from the Singapore HSA in 2021.
Features of the Vanrx SA25, gloveless isolator
Advantages of the Vanrx SA25 system
Available for GMP Production in 2022
A state-of-the-art drug product manufacturing facility equipped with one Syntegon (formerly BOSCH Packaging Technology) isolator filling line for sterile Pre-Filled Syringe (PFS) products with filling volume from 1mL to 3mL in annual capacity of 17 million units.
Drug Product Manufacturing 6 (DP6) is a part of the integrated and dedicated vaccine manufacturing facility located in Dundalk, Ireland. It includes formulation, aseptic filling, lyophilization, capping as well as visual inspection and has the capability for filled vials (semi-finished product) storage.
This dedicated vaccine manufacturing facility assures low contamination risk and product sterility by using integrated online, in-process control solutions to reduce aseptic interventions and process variations. It is designed for BSL (biosafety level) 2/3 and CL (containment level) 2/3 materials and products.
DP7 is a commercial-scale Drug Product (DP) aseptic filling and freeze-drying plant acquired from Bayer in April 2020. This world-class facility provides entire DP manufacturing services including isolator decontamination, vial washing, depyrogenation, sterile filling and stoppering, lyophilization, capping, automatic visual inspection and tray loading.
GMP Available in H2 2021
WuXi Biologics acquired this 50,0000sq. m. 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 that has been operational for GMP production since 2018. Site also includes drug substance production capabilities (MFG 20).
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.