Custom Protein Generation

Drug Substance Manufacturing

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 enable global partners and benefit patients worldwide

Our Company

WuXi Biologics (stock code: 2269.HK), a Hong Kong-listed company, is a leading global open-access biologics technology platform offering end-to-end solutions to empower organizations to discover, develop and manufacture biologics from concept to commercial manufacturing. Our company history and achievements demonstrate our commitment to providing a truly ONE-stop service offering and strong value proposition to our global clients. As of December 31, 2018, there were a total of 205 integrated projects, including 97 projects in pre-clinical development stage, 94 projects in early-phase (phase I and II) clinical development, 13 projects in late-phase (phase III) development and 1 project in commercial manufacturing. With total estimated capacity of biopharmaceutical production planned in China, Ireland, Singapore and US reaching 280,000 liters by 2022, we will provide our biomanufacturing partners with a robust and premier-quality global supply chain network.

Learn more about our services & solutions

Integrated – Expertise – Quality – Capacity

See the benefits of WuXi Biologics’ 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 true, open-access, single-source biologics technology platform from concept to commercialization. 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.

WuXi Biologics Overview Video

View this video to understand our mission, capabilities and core strengths

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 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)
  • 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)
  • Initiated cGMP Manufacturing in the World’s Largest Biologics Manufacturing Facility Using Only Single-Use Bioreactors (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)
  • WuXi Biologics Initiated Construction of a State-of-the-Art Integrated ADC Solution Center (see press release)
  • WuXi Biologics Selected into the Hang Seng HK 35 Index (see press release)
  • WuXi Biologics Commenced Construction of 48,000L Biologics Commercial Manufacturing Center in Shijiazhuang (see press release)
  • WuXi Biologics Commenced Construction of 1.6 million sq. ft. Biologics Innovation Center in Shanghai (see press release)
  • WuXi Biologics Commenced Construction of the Largest Biomanufacturing Facility Using Single-Use Bioreactors in Ireland (see press release)
  • WuXi Biologics Achieves Breakthrough Titer of 51g/L in Cell Culture Productivity (see press release)
  • 1st Biologics company in China approved by both U.S. FDA and EMA (see press release)

Awards and Recognition

  • 2014 ISPE “Facility of the Year” Honorable Mention award (see press release)
  • 2016 WuXi Biologics Receives Asia Pacific Biologics CMO Growth Excellence Leadership Award from Frost & Sullivan (see press release)
  • 2017 WuXi Biologics Receives Asia-Pacific Best Bioprocessing Excellence Award from IMAPAC (see press release)
  • 2017 WuXi Biologics Receives Best IPO Award and Best Investor Relations Award (see press release)
  • 2017 WuXi Biologics Receives Asia’s CMO of 2017 from BioPharma Industry Awards (see press release)
  • 2018 WuXi Biologics Receives Two Bioprocessing Awards from IMAPAC (see press release)
  • 2018 WuXi Biologics Wins CMO Leadership Award from Life Science Leader Magazine (see press release)
  • 2019 WuXi Biologics Receives “Asia’s Best CMO of 2018” Award from IMAPAC (see press release)
  • 2019 WuXi Biologics Wins 2019 CMO Leadership Awards in All Six Categories (see press release)
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