Clinical Manufacture

Commercial Manufacture

Drug Product Fill & Finish

Development

Testing

Discovery

Antibody Drug Conjugates

Technologies & Platforms

Our scientific expertise and multifunctional project teams are capable of efficiently transferring the sponsor methods, assays and processes. The transfer of information and initial method verification provide both WuXi Biologics and the sponsor with a defined baseline to measure the effects of operating procedures, raw materials, manufacturing scale-up, process optimization, protein characterization and product release criteria.

Process transfer from development to manufacturing

  • Establishment and transfer of scale-down models
  • Process transfer reports
  • Face-to-face team meetings
  • Perform satellite runs on-site
  • Local support

Assay transfer from development to QC

  • Analytical development reports & SOPs
  • Face-to-face lab transfer and team meetings
  • On-site training and trouble shooting

Technology Transfer Oversight Committee

  • Tech transfer guidelines
  • Establishment of tech transfer teams, meetings and client communication

Technology Transfer to clients and/or third parties

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