WuXi Biologics
Offering End-to-End Solutions
WuXi Biologics operates multiple state-of-the-art, world-class drug product (DP) manufacturing facilities for the formulation, fill, labelling and packaging of biotherapeutics and vaccines as well as liquid and lyophilized parenterals. We currently maintain 11 drug product facilities capable of conducting liquid or lyophilized fills at varying clinical and commercial scales and utilizing a variety of container and closure system (CCS) configurations that include vials, prefilled syringes and other combination product CCS.
All of our facilities provide isolator-based, fully-automated final drug product formulation and filling under 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 provided cGMP drug product for clinical and commercial use in a variety of countries and regions such as the US, EU, China, Japan, South Korea, Singapore, Australia, Israel and India.
The success of our GMP drug product operations is also due in part to our concept to commercialization drug development platform, extensive GMP drug substance manufacturing network, outstanding quality system and excellence in project execution (see “The WuXi Biologics Difference” short videos for more information). For details on each DP facility, click the corresponding links below.
Available for GMP Production Since 2013
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 220,000 sq. ft. drug substance MFG1 manufacturing 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. This drug product fill site is ideal for a wide variety of biologics (e.g., monoclonal, bispecific and multispecific antibodies, fusion proteins, enzymes and other recombinant proteins) and aqueous non-cytotoxic and non-antibiotic small molecule parenterals
Available for GMP Production Since 2021
A state-of-the-art Drug Product manufacturing facility equipped with one isolator-based IMA integrated filling line and two 20 m2 IMA lyophilizers for sterile vial products with filling volume from 2R to 50R and an annual capacity of up to 10 million vials.
Additional equipment includes:
WuXi Biologics only utilizes the highest-qualified containers, closures and raw materials provided by the world’s leading suppliers.
Available for GMP Production Since 2019
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.
Also Available
Available for GMP Production Since 2019
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 has passed inspections from the U.S. FDA and China NMPA and received a GMP conformity assessment from the Singapore HSA in 2021.
Features of the Vanrx SA25, gloveless isolator
Available for GMP Production Since Q2 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.
This world-class facility was designed to meet global GMP regulatory standards for both clinical- and commercial-scale fills and to be efficiently customized to meet our client’s specific product specifications and demands.
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 (single product – single client) 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.
Capacity and Capabilities
Available for GMP Production Since 2020
DP7 is a commercial-scale Drug Product (DP) aseptic filling and freeze-drying plant acquired from Bayer in April 2020. This 13,000 m2 world-class facility provides entire DP manufacturing services using a flexible isolator-based and state-of-the-art Optima filling system. The system includes automated loading/unloading, isolator decontamination, vial washing, depyrogenation, sterile filling, stoppering, capping, lyophilization, automatic visual inspection and tray loading.
Capacity and Capabilities
Available for GMP Production Since 2021
The WuXi Biologics DP8 Hangzhou drug product (DP) fill site provides the full scope of DP manufacturing services for biologics and vaccines. This site utilizes two, state-of-the-art Vanrx Pharma single-operator, fully-automated, robotic and gloveless isolator systems capable of filling an annual capacity of four million vials or Pre-Filled Syringes (PFS). Beyond GMP manufacturing, services include process development, tech transfer, facility fit, and robustness evaluation of DP manufacturing processes.
For more information on the Vanrx system advantages – click here.
Available for GMP Production Since 2021
WuXi Biologics acquired this 50,0000 m2 state-of-the-art biologics manufacturing facility as well as its labor force from Pfizer China (“Pfizer”) in March 2021. The site has been operational for GMP production since 2018 and WuXi Biologics began GMP production in 2021. Site also includes drug substance production capabilities (MFG 20).
Available for GMP Production Since 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 acquired a drug substance facility (MFG21), and a drug product facility (DP11) for liquid and lyophilization fills, to help expand the company’s global DS and DP capacity.
Available for GMP Production in H2 2023
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 and is ideal for multi-product facilities. This isolator is within a Grade C environment and can achieve as low as ISO 2 level particle counts.
Features of the Vanrx SA25, gloveless isolator
Available for GMP Production Since 2021
This world-class clinical- and commercial-scale drug product labelling and packaging facility is designed and constructed to meet United States, European Union and Chinese cGMP requirements and has passed multiple EMA and NMPA inspections since the facility was first released for GMP activities in 2021.
The facility is located within one of our existing commercial-scale drug product GMP manufacturing facilities and near to several of our other drug product manufacturing facilities in Wuxi, China. This center is equipped with an anti-forgery drug tracking system and automatic labeling machine and is operated by experts with decades of global GMP experience.
As an integral part of the WuXi Biologics comprehensive Contract Research, Development and Manufacturing Organization (CRDMO) drug development service platform, the DPPC provides end-to-end labelling and packaging services which can be customized to meet market demands and regulatory requirements. This center also can deliver a wide range of secondary and tertiary packaging solutions.
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