China approved by both the U.S. FDA and EMA
WuXi Biologics provides a comprehensive, integrated and highly customizable range of services for the discovery, development and manufacturing of biologics. We are a leading global 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 truly ONE integrated and open-access service platform greatly expedites drug development.
Utilizing our one-stop service offering, single project management team, industry leading scale-out manufacturing strategy 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
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 Biologics’ leadership team consists of industry experts with 20+ years of experience in biological drug development in the U.S./EU. While at WuXi Biologics this team has contributed to 1 BLA and 80 worldwide INDs.
WuXi Biologics has over 300+ 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 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 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 and in 2018 we were approved by the U.S. FDA to produce commercial drug substance and drug product (see press release).
Partners worldwide including 13 of the 20 largest pharma
Successful client GMP audits
Global IND-enabling CMC projects for our clients since 2014
BLA for which we manufactured the drug substance and drug product
Capacity and Capabilities
WuXi Biologics has strong technical capabilities and an open-access technology platform that allows our customers to initiate a project at any stage in the discovery and development process. We provide 5 discovery platforms for lead identification and have assembled one of the largest development teams in the global biologics industry with over 2,000 scientists and engineers. We also operate one of the world’s largest cell culture development laboratories with over 260 bioreactors with individual capacity ranging from 1L to 200L. We operate multiple clinical and commercial drug substance and drug product manufacturing facilities, including the world’s largest disposable bioreactor-based biologics commercial manufacturing facility. Our current GMP manufacturing capacity is 40,000 L and growing to 220,000 L across four countries by 2021.
We provide 5 technology platforms and a fully integrated discovery engine that includes custom protein generation and antibody developability and manufacturability assessment.
With one of the world’s largest biologics development teams we cover all aspects of your product development including cell line engineering, assay, formulation and upstream and downstream process development.
We maintain Asia’s first non-state run biosafety lab for viral clearance, CLC and UPB testing. Protein characterization, release and stability testing is also available in-house.
We utilize disposable bioreactors for fed-batch and perfusion manufacturing (50 L to 2,000 L) in two separate facilities (Wuxi and Shanghai).
We have constructed the world’s largest disposable bioreactor-based biologics commercial manufacturing facilities with a manufacturing capacity of 30,000L.
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.
WuXi Biologics Overview Video
View this video to understand our
mission, capabilities and core strengths
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.