Telephone sharing button Contact Us linkedin sharing button LinkedIn mailbox sharing button
arrow_left sharing button
arrow_right sharing button


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.

8 upstream development labs are equipped with a wide variety of cell culture production systems and analytical tools such as 1L to 15L traditional glass bioreactors, perfusion systems to support intensified and/or continuous processes, high throughput AMBRTM systems (AMBR15 and AMBR250), Finesse and Applikon Controllers with Delta V systems, Wave bioreactors, and Cedex Bio HT high throughput bio-analyzers.


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, that include:


  • Aggregation control
  • Charge variant control
  • Glycosylation optimization
  • Sialic acid content optimization
  • ADCC and CDC activity optimization

You are leaving WuXi Biologics Website, after which our Privacy Notice will not apply. Please keep it in mind the protection of your privacy. Are you willing to proceed?