WuXi Biologics
Offering End-to-End Solutions
As the leading Contract Research, Development and Manufacturing Organization (CRDMO), our comprehensive end-to-end microbial platform solutions beginning from strain development to CMC dossier and regulatory support harness our highly-trained staff and state-of-the-art global quality systems, which have continually completed multiple rigorous rounds of regulatory agency inspections. We support cGMP manufacturing of both DS and DP to effectively meet your preclinical, clinical and commercial supply needs in a cost-efficient manner.
Our large-scale microbial-based manufacturing facility is designed and constructed based on U.S., EU and China cGMP requirements. The site utilizes the same comprehensive quality systems implemented by all of our global GMP facilities. Site details include:
WuXi Biologics provides a full scope of drug product (DP) manufacturing services for microbial fermentation-derived therapeutics and vaccines, which includes process development, tech transfer, facility fit, robustness evaluation of DP manufacturing process.
Highly flexible and automated DP GMP manufacturing
Fully-automated, robotic, gloveless, isolator-based Vanrx aseptic drug product fill system at WuXi Biologics
In addition to Hangzhou site, fill of biologics and vaccines drug substance produced via microbial fermentation can also be performed in our various manufacturing facilities globally, including lyophilized dosage forms.
Our dedicated team of highly-trained and experienced professionals allows us to offer: