Custom Protein Generation

Drug Substance Manufacture

Drug Product Fill & Finish

Development

Testing

Discovery

Antibody Drug Conjugates

Technologies & Platforms

Our Mission

To accelerate and transform discovery, development and manufacturing in the fast growing field of biologics to benefit patients worldwide.

Our Company

WuXi Biologics, a Hong Kong-listed company, is a leading global biologics services provider that offers comprehensive, integrated and highly customizable services. The company offers multinational pharmaceutical and biotechnological companies in the world end-to-end solutions empowering anyone and any company to discover, develop and manufacture biologics from concept to commercial manufacturing. Our services are designed to help our worldwide clients shorten the discovery and development time and lower the cost of biologics.

Learn more about our services & solutions

Integrated – Expertise – Quality – Capacity

See the benefits of WuXi’s truly ONE services

Our History

Originally established in 2010 as one of the WuXi AppTec business units, we supported the biologics industry by first offering cell line development and analytical protein characterization services. Over the course of the next 5 years the business unit steadily and aggressively added discovery, development, testing and GMP manufacturing capabilities and the necessary facilities and scientific personnel to provide the pharmaceutical industry the first and only true open-access, single-source biologics technology platform from concept to commercialization. Thus in 2015, WuXi Biologics was incorporated and in June 2017, WuXi Biologics went public on the Hong Kong Stock Exchange (HKEX) becoming one of the top 10 IPOs on the HKEX that year.

Capabilities Timeline:

2010
Analytical Protein Characterization (Shanghai)
Assay Development (Shanghai)
Cell Line Engineering & Development (Shanghai)
Custom Protein Generation (Shanghai)

2011
Mammalian Cell Culture Process Development (Shanghai)
Purification Process Development (Shanghai)
Formulation Development (Shanghai)

2012
Pilot Drug Substance and Drug Product Manufacture (Shanghai)
Antibody Discovery Services (Shanghai)
Medimmune and WuXi Joint Venture

2013
Clinical Drug Substance GMP Manufacture (Wuxi city)
Clinical Drug Product GMP Manufacture (Wuxi city)
QC Lot Release and Stability Testing (Wuxi city)

2014
Antibody Drug-Conjugate GMP Manufacture (Shanghai & Wuxi city)
Perfusion Cell Culture GMP Manufacture (Shanghai & Wuxi city)
Lyophilization Formulation & DP Manufacture (Shanghai & Wuxi city)

2015
Biosafety Testing & Viral Clearance (Suzhou)
Regulatory Services: Registration, Clinical Trial & Market Approval Application Support

2016
Commercial Scale DS & DP GMP Manufacture (Wuxi city)
Commercial Scale Perfusion Manufacture (Wuxi city)
Cell Bank GMP Manufacture

2017
Custom Protein Generation (Wuxi city)
Mammalian Cell Culture Process Development (Wuxi city)
Purification Process Development (Wuxi city)

2018
Clinical Drug Substance GMP Manufacture (Shanghai)

Milestones

  • 1st innovative biologic co-development joint venture in China (see press release)
  • 1st innovative ADC development/manufacturing partnership in China (see press release)
  • 1st sterile biologic product manufactured in China for use under a U.S. FDA IND (see press release)
  • 1st biologics manufactured in China for use in a European clinical trial (see press release)
  • 1st biological product (Antibody drug conjugate) manufactured in China for use in a Australian clinical trial (see press release)
  • 1st non-state affiliated biosafety testing laboratory in Asia (see press release & related story)
  • Constructing the world’s largest mammalian cell culture GMP facility using single-use bioreactors (see press release)
  • Constructed Asia’s largest perfusion biologics manufacturing facility using disposable bioreactors (see press release)
  • 1st integrated biologics R&D center in China providing service platform from discovery to clinic (see press release)
  • WuXi Biologics conducts IPO and is officially listed on the Hong Kong Stock Exchange (see press release)
  • The U.S. FDA completes Pre-License Inspection (PLI) of WuXi Biologics cGMP manufacturing facility for production of TMB-355/ibalizumab (see press release)
  • WuXi Biologics to invest €325 million to build largest biomanufacturing facility using single-use bioreactors in Ireland (see press release)
  • WuXi Biologics to Build an Integrated Biologics Development, Clinical and Commercial Manufacturing Center in Shijiazhuang (see press release)
  • WuXi Biologics to Invest S$80 Million to Establish a Biologics Manufacturing Facility in Singapore (see press release)
  • WuXi Biologics to Invest $60 Million to Establish a Biologics Production Facility in the United States (see press release)

Awards and Recognition

  • 2014 ISPE “Facility of the Year” Honorable Mention award (see press release)
  • WuXi Biologics Receives 2016 Asia Pacific Biologics CMO Growth Excellence Leadership Award from Frost & Sullivan (see press release)
  • WuXi Biologics Receives Asia-Pacific Best Bioprocessing Excellence Award from IMAPAC (see press release)
  • WuXi Biologics Receives Best IPO Award and Best Investor Relations Award (see press release)
  • WuXi Biologics Receives Two Bioprocessing Awards from IMAPAC (see press release)
  • WuXi Biologics Receives Asia’s CMO of 2017 from BioPharma Industry Awards (see press release)
  • WuXi Biologics Wins CMO Leadership Award from Life Science Leader Magazine (see press release)
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