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Drug Product cGMP Fill

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.

DP1 (Wuxi)


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.

 

  • Capabilities 

 

    • Both liquid and lyophilization formulation and fill
    • Both biologics and aqueous non-cytotoxic and non-antibiotic small molecule parenterals
    • Multiple validated container and closure configurations (2R, 6R, 8R, 10R, 14R, 20R and 50R)

 

  • Equipment 

 

    • Fully automated vial wash, depyrogenation, filling and capping line with Restricted Access Barrier system (RABs) from Bosch offering a capacity from 3,000 to 12,000 vials per hour or 9,000 vials/batch (50R) up to 100,000 vials/batch (2R)
    • Tofflon 5m2 lyophilizer with fully automated loading/unloading, WIT and CIP/SIP offering capacity from 6,000 vials/batch (20R) to 22,400 vials/batch (2R)

 


DP2 (Wuxi)


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.


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)


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 5kg, 50batches/year 
  • Single-use bioreactor (SUB), e.g., disposable glass reactors and plastic wave bioreactors (5, 15, 30, 50, 100, 200,500L) 
  • AKTA Ready, UF/DF system 
  • Mixing tanks (10, 50, 100, 200, 500 and 1,000L)  
  • 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 5m2 & 1 x 20m2 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)


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.


Site Details:

 

Features of the Vanrx SA25, gloveless isolator

 

  • Filling Process: peristatic pump, single head (one filling needle)
  • Filling volume range: 0.5mL – 20mL
  • 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
    • Integrated stopper and cap system
  • Validated vial container and closure configurations: 2R, 6R, 8R, 10R, 20R
  • Validated PFS fill and finish: 1.0mL and 2.25mL

 

Advantages of the Vanrx SA25 system

 

  • Filling Process: peristatic pump, single head (one filling needle)
  • Filling volume range: 0.5mL – 20mL
  • 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
    • Integrated stopper and cap system
  • Validated vial container and closure configurations: 2R, 6R, 8R, 10R, 20R
  • Validated PFS fill and finish: 1.0mL and 2.25mL

DP5 (Wuxi)


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. 


Site Details:

 

  • Isolator-based filling lines for liquid fills
  • Syringe sizes to include 1mL, 2.25mL, 3mL
  • Inline weight check
  • All product contact materials are single-use/disposable elements to prevent cross contamination
  • Nitrogen blanketing available

 

Size

Speed (Units/hour)

1mL

24,000

2.25mL

22,000

3mL

20,000


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.


Site Details:

 

  • Design Concept

 

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.

 

    • 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: 2ml, 20ml
    • High-throughput filling (400 vials/min) with an annual capacity of 35M~45M doses
    • Lyophilization capacity (5 x 33m2 lyophilizer)

DP7
(Leverkusen, Germany)


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.  


Site Details:

 

  • Design Concept

 

    • 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 23m2 freeze dryers)

 


DP9/10 (Hangzhou)


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). 


Site Details:

 

  • Liquid and lyophilized drug product formulation and fill
  • Vial and pre-filled syringe fills available
  • Annual capacity of 10 million units; 1 x 10m2  lyophilizer
  • Onsite Drug Product formulation and fill
  • Site has been GMP-ready since 2018

 


DP11 (Suzhou)


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.


Site Details:

 

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