As a premier Contract Discovery, Development and Manufacturing Organization (CDMO), WuXi Biologics provides our clients worldwide with the necessary expertise, quality and capacities to develop biologic drugs from idea to market. Along with our WuXi AppTec affiliates, we provide the world with the ONE true single-source approach that saves our clients critical time and money.
Our truly ONE integrated and open-access service platform greatly expedites drug development.
Utilizing our one-stop service offering, single project management team and a supply chain only 1-2 hours apart, WuXi Biologics eliminates the time-consuming project hand-offs and troubleshooting issues that come with the conventional multi-vendor drug development model. (Learn More)
The WuXi Biologics Difference
We provide industry-leading experts and solutions from concept to commercialization.
Our track record demonstrates our commitment to meeting global regulatory standards.
We provide the expertise and facilities to get your program efficiently from idea to market.
Let our team help you access one of the largest healthcare markets in the world.
Experience & Expertise
WuXi’s leadership team consists of industry experts with 15-20 years of experience in biological drug development in the U.S./EU. While at WuXi this team has contributed to 1 BLA and 40 worldwide INDs in just 2 years!
WuXi has over 120+ returnees from large pharma and small biotechs in the U.S./EU. These scientists cover all facets of drug development from discovery to manufacture of final drug product.
WuXi Biologics makes training a high priority and all of our 1,200+ scientists and engineers go through rigorous training regimens before working on your critical programs.
Due to our extensive experience and expertise we are uniquely suited to help solve your development dilemmas. Whether your issues are time or technical, our team of industry experts is there to provide solutions.
Quality & Performance
We are the first CDMO in China to provide a quality system and operations that meet worldwide regulatory standards. We have routinely and successfully passed audits by our clients, EU Qualified Persons (QPs) and former U.S. FDA inspectors.
Successful client GMP audits in the past 2 years
Global IND-enabling CMC projects since 2014
Partners worldwide including 12 of the top 20 large pharma
BLA for which we manufactured the drug substance and drug product
Capacity and Capabilities
With over 1,200 highly trained scientists, 5 biologics discovery platforms, over 750,000 sq. ft. of lab and manufacturing space, the world’s largest CDMO development team and coming soon in 2016 the world’s largest mammalian cell culture manufacturing site employing fully disposable bioreactor technology, WuXi Biologics provides you unparalleled capacities and capabilities to meet your drug development needs
WuXi provides 5 mAb discovery platforms and a fully integrated discovery engine that includes research materials generation and antibody developability and manufacturability assessement.
With the world’s largest CDMO development team we cover all aspects of your product development including cell line engineering, assay, formulation and process development.
WuXi Biologics maintains Asia’s only non-state run biosafety lab for viral clearance, CLC and UPB testing. Protein characterization, release and stability testing is also available in-house.
WuXi utilizes single-use bioreactors for fed-batch and perfusion manufacturing (50 L to 2,000 L) in two separate facilities (Wuxi and Shanghai).
We are constructing the world’s largest mammalian cell culture GMP facility using single-use bioreactors for mAb, rprotein and ADC therapeutics.
Fill & Finish
Liquid Drug Product / Parenteral formulation, fill & finish (up to 12,000 vials/hr or 100,000 vials/batch) is available as is lyophilization.
Gateway to China
China has the world’s largest population, 2nd largest economy and 3rd largest healthcare market. Thus, most companies are evaluating how to address China’s unmet medical needs. WuXi Biologics can provide unprecedented regulatory and technical support for any organization looking to enter clinical trials or to market its biotherapeutic in China. Contact us about partnering opportunities in China.
The Joint Venture between Medimmune and WuXi was just the first example of how we are assisting drug development organizations worldwide to bring critical medicine to patients in China.