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Commercial Drug Product (DP) Manufacturing

WuXi Biologics, as a leading Contract Research, Development and Manufacturing Organization (CRDMO), operates multiple state-of-the-art, world-class drug product (DP) manufacturing facilities for the formulation, fill, labelling and packaging of biotherapeutics, vaccines, placebo and parenterals filled into either liquid or lyophilized (if applicable) dosage forms. We perform drug product fills into 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 (FDA), European Medicines Agency (EMA) and National Medical Products Association (NMPA). We have provided cGMP drug product for late-stage clinical and commercial use into 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.

DP1 (Wuxi)


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

 

Site Details:

 

  • Isolator-based filling lines for both liquid and lyophilization fills
  • Multiple validated container and closure configurations (2R, 6R, 8R, 10R, 14R, 20R and 50R)
  • Liquid fills up to 6 million doses/year
  • Fully automated vial wash, depyrogenation, filling and capping line with Open Restricted Access Barrier system (ORABs) from Bosch
  • Offers liquid fill capacity up to 12,000 vials per hour or 7,000 vials/batch (50R) up to 66,000 vials/batch (2R)
  • Tofflon 1 x 5 m2 lyophilizer with fully automated loading/unloading, WIT and CIP/SIP offering lyophilization capacity from 6,000 vials/batch (20R) to 22,000 vials/batch (2R)

DP2 (Wuxi)


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.

Site Details:

 

  • Isolator-based filling lines for both liquid and lyophilization fills
  • Vial sizes to include 2R, 6R, 8R, 10R, 20R and 50R
  • Capable of 100% inline weight check and nitrogen blanketing
  • Option of disposable or stainless steel systems

 

Additional equipment includes:

 

  • Vial and utensil washers
  • Depyrogenation tunnel
  • Filler
  • Two cappers with Active Open Restricted Access Barriers (oRABS)
  • Autoclave

 

WuXi Biologics only utilizes the highest-qualified containers, closures and raw materials provided by the world’s leading suppliers.

DP5 (Wuxi)


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.

 

 

Site Details:

 

  • Isolator-based filling lines for liquid fills
  • Syringe sizes: 1 mL standard, 1 mL long, 2.25 mL, and 3 mL standard from multiple vendors
  • Minimum filling volume: 0.15 mL
  • Maximum filling speed: 400 PFS/min
  • Maximum annual capacity of 17 million (PFS) units
  • Inline weight check
  • All product contact materials are single-use/disposable elements to prevent cross contamination
  • Nitrogen blanketing available for oxygen-sensitive products
  • Yellow light filling available for light-sensitive products
  • Automatic Disinfection Machine to support primary packaging introduction into aseptic filling environment

DP7
(Leverkusen, Germany)


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.  

 

In 2025, an additional line will be installed to enable the filling of prefilled syringes (PFS).

Site Details:

 

  • State-of-the-art technology applied to assure product sterility, including isolators, disposable and stainless-steel (SS) systems with CIP/SIP
  • Facility is adaptable to single-use (SU) processes
  • Fully automated control system for facility and process equipment
  • Physically separated areas for bulking, filling and component prep
  • Integrated online, in-process control solutions to reduce aseptic interventions and process variations
  • Isolator (Grade A) in clean room (Grade C) environment
  • Liquid filling independent of freeze-drying (lyophilization) process
  • Automated lyophilization loading and unloading

 

Capacity and Capabilities 

 

  • Aseptic process-based liquid and lyophilized drug product manufacturing 
  • Vial sizes available: 2R, 6R, 8R, 10R, 20R, 50R
  • High-throughput filling (170  vials/min) with an annual capacity of 5~10M vials
  • Lyophilization capacity (2 x 23 m2 freeze dryers)

 

Expansion of facility 

 

  • Additional line planned for prefilled syringes (PFS)
  • GMP readiness of PFS line planned for end of 2025
  • Expected annual capacity of around 10M PFS
  • PFS formats from 0.5ml to 3ml

Drug Product Packaging Center (DPPC)


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.

 

 

Site Details:

  • Clinical- and commercial-scale packaging
  • Transportation packaging services
  • 30 million vial packaging capacity per year
  • Three vial packaging lines
  • Vial sizes: 2R, 6R, 8R, 10R, 20R and 50R
  • Automated labelling
  • Serialization service with 2 or 3 level aggregation
  • Artwork design
  • Double-blind labelling
  • Coding or UV inscription printing available

DP19 (Singapore)


This liquid and lyophlization dosage form drug product fill facility is part of a 10-year USD$1.4 billion (S$2 billion) investment to establish a cutting-edge, fully integrated CRDMO center in Singapore.  The investment strengthens WuXi Biologics’ global research, development and manufacturing network to meet the growing demand from clients worldwide for end-to-end services, and continues to enable its Global Dual Sourcing strategy.

Site Details:

  • Clinical- and commercial-scale fills for vials and prefilled syringes (PFS)
  • Vials: Up to 10 million doses/year
  • PFS: Up to 17 million doses/year
  • 2 x 20 m2 lyophilization systems