Clinical Manufacture

Commercial Manufacture

Drug Product Fill & Finish

Development

Testing

Discovery

Antibody Drug Conjugates

Technologies & Platforms
   

WuXi Biologics 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 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

Experience &
Expertise

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We provide industry-leading experts and solutions from concept to commercialization.

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Quality &
Performance

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Our track record demonstrates our commitment to meeting global regulatory standards.

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Capacity &
Capabilities

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We provide the expertise and facilities to get your program efficiently from idea to market.

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Gateway
to China

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Let our team help you access one of the largest healthcare markets in the world.

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Experience & Expertise

Experience

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 this team has contributed to 1 BLA and 60+ worldwide INDs.

Expertise

WuXi Biologics has over 200+ 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.

Training

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.

Solution Provider

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.

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Partners worldwide including 13 of the 20 largest pharma 

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Successful client GMP audits

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Global IND-enabling CMC projects for our clients since 2014

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BLA for which we manufactured the drug substance and drug product

Capacity and Capabilities

We have strong technical capabilities and an open-access technology platform that allows our customers to initiate a project at any stage in the development process. We have assembled one of the largest biologics development teams in the global biologics industry with over 2,000 scientists and engineers (as of October 2017). 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 have constructed the world’s largest disposable bioreactor-based biologics commercial manufacturing facilities with a manufacturing capacity of 30,000L.

Discovery

Discovery

We provide 5 technology platforms and a fully integrated discovery engine that includes research materials generation and antibody developability and manufacturability assessment.

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Development

Development

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.

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Testing

Testing

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.

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Clinical
Manufacture

Clinical Manufacture

We utilize disposable bioreactors for fed-batch and perfusion manufacturing (50 L to 2,000 L) in two separate facilities (Wuxi and Shanghai).

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Commercial
Manufacture

Commercial Manufacture

We have constructed the world’s largest disposable bioreactor-based biologics commercial manufacturing facilities with a manufacturing capacity of 30,000L.

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Formulation,
Fill & Finish

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Liquid Drug Product / Parenteral formulation, fill & finish (up to 12,000 vials/hr or 100,000 vials/batch) is available as is lyophilization.

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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.

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