WuXi Biologics
Offering End-to-End Solutions
Beginning from strain development to CMC dossier and regulatory support, our comprehensive, end-to-end microbial production system harnesses highly trained staff and world-class quality systems, which have continually passed multiple rigorous rounds of regulatory agency inspections. We provide expert, efficient development services for vaccines produced via microbial fermentation, regardless of whether your product is nucleic acid- or protein-based. Explore more details of our single-source service offering.
Strain Development
Strain development capabilities include:
Drug Substance (DS) Process Development
Led by a team of experts, we offer batch and fed-batch, and downstream purification process development of molecules in different expression systems. This includes, but is not limited to, intracellular soluble products, inclusion bodies, and extracellular secreted products. Our multi-purpose/multi-product 2,000 m2 process development laboratories facilitate the development of nucleic acid- or protein-based vaccines, supporting IND-enabling toxicology studies, or preclinical and CMC development activities at various scales.
Our capabilities include:
Formulation and Drug Product Development
We provide a dedicated team of highly-trained and experienced scientists capable of developing and optimizing vaccine product formulations filled into a wide variety of container and closure systems (CCS) including combination products (e.g., prefilled syringes and autoinjectors).
Our capabilities include:
Analytical Development
The analytical method development team supports many CMC activities including:
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