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Capabilities

Quality. Expertise. Capacity. Speed. These are cornerstones of every service WuXi Biologics provides across the discovery to commercialization spectrum. Our CRDMO service offering provides unparalleled research, development, manufacturing and testing resources and production capacity to enable our clients to move critical biologics into the clinic and the market faster and more cost-effectively than ever before.

Research Services

Our Contract Research Organization (CRO) services start with initial target identification and assessment and comprise over 10 biologic discovery platforms to move you from target to final lead selection quickly and cost effectively. Included in our CRO services is our high-throughput, high productivity protein generation services to advance all of your R&D efforts across any therapeutic class or research arena.

Development Services

We provide to every client and every project, state-of-the-art technology platforms and extensive scientific expertise from one of the world’s largest and most experienced development teams.

Our Contract Development and Manufacturing Organization (CDMO) services span from initial high-yielding protein generation capabilities to kick-off CMC development activities to cell line development and on to GMP manufacturing of the initial clinical material. We even provide extensive CMC dossier and regulatory support services prior to IND filing. Our industry-leading DNA to IND timelines provide the most cost effective and efficient platforms for you to enter clinical trials and beyond.

Manufacturing Services

We operate over 20 state-of-the-art, premier quality cGMP drug substance and drug product facilities across four countries for the production of a wide array of biologics from both mammalian and microbial expression systems. This expansive manufacturing network provides our clients a global dual source option for clinical and commercial manufacturing. All of our manufacturing operations are overseen by our comprehensive global quality system that has been audited by multiple regulatory agencies including the U.S. FDA, EMA and NMPA.

Testing Services

We provide extensive in-house analytical and biosafety testing support of all discovery, development and manufacturing activities. Testing services include in-process, release and stability method development, product and cell line characterization and EMA, ISO (CNAS) and CMA certified Quality Control (QC) laboratories.

Multiple testing “Centers of Excellence” (CoEs) that provide state-of-the-art equipment and highly-trained scientific teams provide standalone analytical services across a wide range of disciplines including forensic, bioassay, process impurity and biophysical analysis of various biologic product modalities.

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