Clinical Manufacture

Commercial Manufacture

Drug Product Fill & Finish

Antibody Drug Conjugates

Technologies & Platforms

Our Mission

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

Our Company

WuXi Biologics (A WuXi AppTec Affiliate) provides a comprehensive, integrated and highly customizable range of services for the discovery, development and manufacturing of biologics. We are the only open-access biologics technology platform in the world offering end-to-end solutions to empower anyone to discover, develop and manufacture biologics from concept to commercial manufacturing. We provide the world with the ONE true single-source approach that saves our clients critical time and money. Our company history and achievements demonstrate our commitment to providing a truly ONE-stop service offering and value proposition to our global clients.

Learn more about our services & solutions

Integrated – Expertise – Quality – Capacity

See the benefits of WuXi’s truly ONE services

Our History

WuXi Biologics (Cayman) Inc is a WuXi AppTec affiliate. Originally established in 2008 as one of the WuXi AppTec business units it supported the biologics industry by first offering cell line development and analytical protein characterization services. Over an eight year period the business unit steadily and aggressively built the world’s first true concept to commercialization service and open-access technology platform for the biologics industry.

Capabilities Timeline:

Cell Line Engineering & Development (Shanghai)
Research Materials Generation (Shanghai)

Analytical Protein Characterization (Shanghai)
Assay Development (Shanghai)

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

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

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

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

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

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

Milestones, Awards and Recognition

  • 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)
  • 2014 ISPE “Facility of the Year” Honorable Mention award (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 Receives Asia-Pacific Best Bioprocessing Excellence Award from IMAPAC (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)