WuXi Biologics
Offering End-to-End Solutions
Upstream Process Development
We offer state-of-the-art cell culture development labs and a non-GMP pilot plant specializing in the process development, characterization, validation and process scale-up to establish successful cGMP clinical and commercial manufacturing. To support all stages of vaccines development from preclinical to commercial production, we employ traditional fed-batch, continuous, and/or intensified processes based on your specific project needs.
Eight upstream development labs are equipped with a wide variety of cell culture production systems and analytical tools such as 1 to 15 L traditional glass bioreactors, perfusion systems to support intensified and/or continuous processes, high-throughput AMBR systems (AMBR15 and AMBR250), Finesse and Applikon Controllers with Delta V systems, Wave bioreactors, and Cedex Bio HT bioanalyzers.
IND-enabling cell culture activities
- Clone selection, process optimization, scale-up and toxicology material production
- Technical transfer to GMP production teams
Early stage (Phase I-II) and late stage (Phase III) cell culture process development
- Technical transfer
- Commercial process development
- Process characterization and validation
- IND and BLA CMC dossier support
Stand-alone projects
- Media screening and adaptation
- Material generation at various scales of production
- Process or unit step development and optimization, including harvest steps
Product Quality Optimization
Product quality optimization is an essential part of bioprocess development. We have developed a comprehensive toolbox for the optimization of various product quality attributes, including:
- Aggregation control
- Charge variant control
- Glycosylation optimization
- Sialic acid content optimization
- ADCC and CDC activity optimization
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