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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 cGMP 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 parenteral
  • Multiple validated container & closure configurations (2R, 6R, 8R, 10R, 14R, 20R and 50R)

Equipment/Capacity

  • Fully automated vial washing, 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 84,000 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) – cGMP 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. The 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
  • Options 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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A facility designed for the cGMP 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 is designed to handle OEB5 (or Safebridge III or IV) compounds used as payloads or toxins. The facilities meet U.S. FDA, EMA, and NMPA cGMP 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 the 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 cGMP 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 cGMP-ready since Q2 2019. To see the significant advantages of the Vanrx system – click here.

Capabilities of the Vanrx SA25, gloveless isolator-based system at WuXi Biologics 

  • Filling Process: peristaltic pump
  • Utilizes Ready-to-Use (RTU) Containers Closure Systems (CCS)
  • Multiple validated CCS types (see tables below): Vial and PFS (Cartridge fill & finish available H2 2020)
  • Fully automated, programmable and robotic filling processes
  • Weight check: 100% or statistical IPC, either destructive or non-destructive
  • Automated and integrated EM and in-process control checks
  • Integrated stopper & cap system to simplify filling and provide greater quality assurance
  • Automated and integrated Electronic Batch Record system

Advantages of the Vanrx SA25 system

The Vanrx robotic, programmable and isolator-based systems offer significant advantages for multi-product facilities compared to conventional fill lines due to its inherent flexibility and ability to substantially reduce risk. To learn more about advantages click here.

DP4 Manufacturing Capacity

PFS 

CCS Unit/Nest Full load (vials) Batch size with 3 full loads (vials) Units/Min
1ml long syringe 160 4000 12000 30
1.0-3.0 ml* 100 2500 7500 25
5.0 ml* 64 1600 4800 16
10.0 ml* 42 1050 3150 10

Vials 

CCS Unit/Nest Full load (vials) Batch size with 3 full loads (vials) Units/Min
2R, 4R 100 2400 7200 25
6R, 8R, 10R, 15R 48 1152 5000** 12
20R, 25R*, 30R* 25 600 1800 7
50R* 16 384 1152 5

*These vial and PFS configurations are currently under development and will be available in the future. **Can fill 5 loads and batch size up to 5000 vials.

Scalability of the Vanrx System

The Vanrx systems is compatible with the WuXi Biologics “scale-out” and “Global Dual Sourcing” manufacturing paradigms. Future WuXi Biologics DP facilities will contain 2 – 6 units per facility. The small footprint and simplified qualification and validation plan allows for multiple systems to be used in the same facility and allows for faster capacity expansion.

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Leverkusen, Germany (DP7) – cGMP Available Q4 2020

DP7 is a commercial-scale Drug Product (DP) aseptic filling and freeze drying plant acquired from Bayer in April of 2020. This world-class facility utilizes an integrated isolator system for the entire DP manufacturing operation including vial washing, depyrogenization, sterile filling & stoppering, freeze drying (lyophilization), capping and tray loading.

Design Concept

  • State-of-the-art technology applied to assure product sterility, including isolators, disposable and stainless steel (SS) systems with CIP/SIP
  • Fully electronic process control system to cover the whole facility
  • Personnel flow and material flow are designed to prevent cross-contamination during concurrent tasks
  • Integrated on-line 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 (row by row)

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 (two 23 m2 freeze dryers)

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Summary – Current Drug Product Global Capacity

Site DP Capability cGMP Ready Location Capacity
DP1 Liquid vial with lyophilization; clinical and commercial FFF 2013 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 Single-operator,
fully-automated, robotic and gloveless isolator Liquid 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 cGMP Ready Location Capacity
DP2 Liquid vial with lyophilization;  Commercial-scale 2021 Wuxi, China 10 million vials/yr (liquid)

2 x 20 m2 lyophilization

DP5 Pre-filled syringe (PFS); Commercial-scale 2022 Wuxi, China >10 million PFS/yr
DP6 Pre-filled syringe (PFS); Commercial-scale 2022 Dundalk, Ireland 60 million vials/yr (lyo)

4 x 32 m2 lyophilization

DP7 Liquid vial with lyophilization;   Commercial-scale Q4 2020* Leverkusen, Germany 10 million vials/yr (liquid)

2 x 23 m2 lyophilization

*WuXi Biologics and Bayer Enter into an Acquisition Agreement on a Drug Product Plant in Germany

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

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