Custom Protein Generation

Drug Substance Manufacturing

Drug Product Fill & Finish

Development

Testing

Discovery

Antibody Drug Conjugates

Technologies & Platforms
WuXi Biologics Successfully Completed
First FDA Routine GMP Inspection
WuXi Biologics is the first biologics company in
China approved by both the U.S. FDA and EMA
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WuXi Biologics operates multiple state-of-the-art world-class drug product (DP) manufacturing facilities for the fill and finish of protein/antibody biotherapeutics and liquid or lyophilized parenterals. All of our facilities provide fully-automated final drug product formulation and filling under cGMP conditions as defined by the worldwide regulatory agencies including U.S. FDA, EMA and NMPA. We have also provided GMP drug product for clinical trials in other countries such as Japan, Korea, Singapore, Australia, Israel and India. To see details on each facility, click the corresponding links below:


Wuxi city (DP1)

Capabilities

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

Equipment/Capacity

  • Fully automated vial wash, depyrogenation, filling and capping line with Restricted Access Barrier system (RABs) from Bosch offering a capacity of from 3,000 to 12,000 vials per hour or 9,000 vials/batch (50R) up to 100,000 vials/batch (2R).
  • Tofflon 5 square meter lyophilizer with fully automated loading/unloading, WIT and CIP/SIP offering capacity from 6,000 vials/batch (20R) to 22,400 vials/batch (2R)
  • Flexible small-scale sterile filling, up to 3000 vials per batch, with Nitrogen blanketing (Flexicon bench-top filling line)

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To learn more or receive a quote for Drug Product manufacture click here

Wuxi city (DP2) – GMP Available 2021

State-of-the-art DP manufacturing facility equipped with one IMA filling line and two 20m2 IMA lyophilizers to manufacture sterile vial products from 2ml to 50ml. Facility will maintain an annual capacity of 5-10 million vials.

  • Isolator-based filling lines for both liquid & lyo fills
  • Vial sizes to include 2R, 6R, 8R, 10R, 20R & 50R
  • Capable of 100% in-line weight check
  • Option of disposable or dedicated stainless steel systems

Additional equipment includes:

  • Vial and utensil washers
  • Depyrogenation tunnel
  • Filler
  • Two cappers with ORABS
  • Autoclave

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Wuxi city (DP3)

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Facility designed for the GMP manufacture of bioconjugate (e.g., Antibody Drug Conjugates (ADCs) Drug Substance and Drug Product. The site will feature an OEB5 Isolator for payload and linker weighing and dissolution and all product contact surfaces will utilize single-use systems to minimize risk throughout the manufacturing process. This facility was designed to handle OEB5 (or Safebridge III or IV) compounds used as payloads or toxins. The facilities meet U.S. FDA, EMA and NMPA GMP standards.

  • Fully-automated processing throughout formulation and filling process
  • Multiple validated container and closure configurations of 2R, 6R, 10R and 20R
  • Liquid filling up to 100,000 vials/batch/day (2R vial)
  • Lyophilized DP capacity up to 25,000 vials/batch/day (2R vial)

Also Available

  • Nitrogen blanketing
  • Light protected material handling from start of fill processing to final package steps
  • Liquid and lyo fills for Parenterals (e.g., small molecule and peptide therapeutics)

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

Wuxi City (DP4)

This state-of-the-art GMP manufacturing facility is equipped with the Vanrx Pharmasystems SA25 single-operator, fully-automated, robotic and gloveless isolator capable of filling an annual capacity of 5 million vials or Pre-Filled Syringes (PFS). This modular “workcell” 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 and successfully completed all media-fill requirements.

Features of the Vanrx SA25, gloveless isolator 

  • Filling Process: peristatic pump, single head (1 filling needle)
  • Filling volume range: 0.5 mL – 50 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
  • Integrated stopper & cap system
  • Validated vial container and closure configurations: 2R, 6R, 8R, 10R
  • Validated PFS fill and finish:  0.5mL and 1.0mL

Advantages of the Vanrx SA25 system

  • Flexible – dual format filling for both vial and PFS
  • Ideal for multi-product production
  • Faster changeover compared to traditional filling lines
  • All product contact surfaces utilize single-use / disposable elements to prevent cross contamination
  • Robotic, gloveless, sterile filling requires no human intervention thus significantly reducing contamination potential and user-error events
  • Integrated stoppering and capping functionality further reduces risk
  • Ability to use RTU containers and closures help eliminate rejection rates due to particles and defects that are common in traditional closure components

 

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Summary – Current Global Capacity

Site DP Capability GMP Ready Location Capacity
DP1 Liquid vial with lyophilization; clinical and commercial FFF 2012 Wuxi city Liquid fill range from 9,000 vials/batch (50R) up to 100,000 vials/batch (2R)

Lyo fill range from 6,000 vials/batch (20R) up to 22,400 vials/batch (2R)

DP3 Liquid vial with lyophilization; clinical FFF 2019 Wuxi city Liquid 100,000 vials/batch (2R vial)

Lyo fill up to 25,000 vials/batch (2R vial)

DP4 Vanrx Pharmasystems SA25 single-operator,
fully-automated, robotic and gloveless isolatorLiquid vial and Pre-Filled Syringe (PFS); clinical FFF
2019 Wuxi city Up to 5 million vials or PFS/year

 

Summary – Future Planned Expansion of Global Drug Product Capacity

Site DP Capability GMP Ready Location Capacity
DP2 Liquid vial with lyophilization;  Commercial-scale 2021 Wuxi city 5-10 million vials/yr
DP5 Pre-filled syringe (PFS); Commercial-scale 2021 Wuxi city TBD

To learn more about WuXi Biologics’ truly ONE services
or to receive a quote – Click Here

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