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Drug Product (DP) cGMP Manufacturing & Fill

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.

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 Restricted Access Barrier system (RABs) from Bosch
  • Offers liquid fill capacity from 3,000 to 12,000 vials per hour or 9,000 vials/batch (50R) up to 100,000 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 22,400 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.

DP3 (Wuxi)


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. 

Site Details:

 

  • Conjugation capability up to 5 kg, 50batches/year 
  • Single-use bioreactor (SUB), e.g., disposable glass reactors and plastic wave bioreactors (5, 15, 30, 50, 100, 200, and 500 L) 
  • AKTA Ready, UF/DF system 
  • Mixing tanks (10, 50, 100, 200, 500 and 1,000 L)  
  • Fully automated processing throughout formulation, filling and lyophilization process 
  • Multiple validated container and closure configurations of 2R, 6R, 10R, 20R and 50R
  • Liquid filling up to 100,000 vials/batch/day (2R vial) or three million doses per year
  • Lyophilized DP capacity  includes 1 x 5 m2 & 1 x 20 m2 units (up to 25,000 vials/batch/day [2R vial])

 

Also Available 

 

  • Nitrogen blanketing
  • Yellow light protected material handling from the start of formulation and fill processing to final package steps
  • Liquid and lyophilization fills for parenteral products (e.g., small molecule and peptide therapeutics)

DP4 (Wuxi)


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.

Site Details:

 

Features of the Vanrx SA25, gloveless isolator

 

  • Filling Process: peristatic pump, single head (one filling needle)
  • Filling volume range: 0.5 mL – 20 mL
  • Weight check: 100% or statistical IPC, either destructive or non-destructive
  • Max speed: 30  units/min
  • Automated EM and in-process control checks
  • Utilizes Ready-to-Use (RTU) containers and closures with integrated stopper and cap system
  • Validated vial container and closure configurations: 2R, 6R, 8R, 10R, 20R
  • Validated PFS fill: 1.0 mL and 2.25 mL

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

DP6 (WuXi Vaccines)


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.

Site Details:

 

  • Isolators, disposable and stainless-steel (SS) systems with CIP/SIP
  • Fully automatic/digital process control
  • Online automated visual inspection system 
  • Isolator (Grade A) and oRABS technology
  • Liquid filling independent of lyophilization process
  • Automated loading and unloading system integrated with multiple lyophilizer

 

Capacity and Capabilities

 

  • Aseptic process-based liquid and lyophilized drug product manufacturing
  • Vial sizes available: 2 ml, 20 ml
  • High-throughput filling (400 vials/min) with an annual capacity of 35M~45M doses
  • Lyophilization capacity (5 x 33 m2 lyophilizer)

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.  

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 (200  vials/min) with an annual capacity of 5~10M vials
  • Lyophilization capacity (2 x 23 m2 freeze dryers)

 

DP8 (Hangzhou)


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.

 

 

Site Details:

 

  • 2× Vanrx SA25 robotic aseptic filling lines for clinical DP manufacturing of biologics and vaccines
  • Extensive flexibility to support the complex drug filling processes of BSL-2 viral vaccines
  • Aseptic formulation for Alum adjuvanted vaccines
  • Flexible container-closure systems including vials (2R to 20R) and prefilled syringes (1 mL to 3 mL long and normal). All primary packaging materials are ready-to-use (RTU)
  • Single-use systems covering the entire equipment train with no shared product contact surfaces

 

For more information on the Vanrx system advantages – click here.

DP9/10 (Hangzhou)


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). 

Site Details:

 

 

  • Liquid and lyophilized drug product formulation and fill in vials and PFS
  • DP9 vial fill site:
    • Annual capacity of 6 million doses
    • IMA filling line with isolator system, and 1 x 10 m2 lyophilizer from ALUS
    • Vial sizes to include 2R, 6R, 10R, 20R, 30R and 50R
  • DP10 PFS fill site:
    • Groninger FlexPro isolator nested syringe (PFS) filler
    • Annual capacity up to 7 million doses

DP11 (Suzhou)


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.

Site Details:

 

  • Liquid and Lyophilization Drug Product Fills
  • GMP Fed-Batch Cell Culture: 7,000 L
  • Process development laboratories

 

DP12 (Cranbury, NJ)


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

 

  • Vial and prefilled syringe (PFS) fills
  • Filling process: peristatic pump, single head (one filling needle)
  • Filling volume range: 0.5 mL – 20 mL
  • Weight check: 100% or statistical IPC, either destructive or non-destructive
  • Max speed: 30  units/min
  • Automated EM and in-process control checks
  • Can also utilize Ready-to-Use (RTU) containers and closures with integrated stopper and cap system
  • Vanrx Aseptic Filling system includes decontamination and staging isolator (DSI), filling isolator (FI) and stoppering chambers (SC)​

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)


Available for GMP in 2026

 

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
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