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 high-standard global quality systems, which have continually completed multiple rigorous rounds of regulatory agency inspections. We provide expert, highly-efficient development services for biologics and vaccines produced via microbial fermentation, regardless of whether your product is nucleic acid- or protein-based. See below for more details on our one-stop service offering.
Strain development services include:
Led by a team of experts, we offer batch and fed-batch (including high-density 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 biotherapeutics and vaccines, supporting IND-enabling toxicology studies, or preclinical and CMC development activities at various scales.
Our capabilities include:
The analytical method development team supports many CMC activities including:
We provide a dedicated team of highly-trained and experienced scientists capable of developing and optimizing biologics and vaccines product formulations filled into a wide variety of container and closure systems (CCS) including combination products (e.g., prefilled syringes and autoinjectors). The drug product development team also manages process scale-up and performance qualification activities and technology transfer to GMP operations.
Our capabilities include: