Services

Technology Transfer includes:

1. Process Feasibility Assessment:
   • Technical and commercial evaluation of process fit to facility and equipment
2. Knowledge Transfer:
   • Demonstration of current process at lab scale
   • Identification of critical control parameters
   • Process flow design to identify equipment and process train in facility
   • Analytical transfer and alignment by R&D Analytical Services team
3. Process and Analytical Development:
   • Design of Experiment (DOE)
   • Upstream and downstream optimization
   • Pilot scale production
4. Operational Transfer & Large-Scale Production
   • Integration of process into quality management system (QMS)
   • Analytical method qualification and validation
   • Manufacture of Development, Engineering & Process Qualification (PQ) batches
   • QC testing
   • Quality Assurance (QA) batch review and release process
5. Knowledge Management
   • Project history files
   • Campaign reports

Contract Manufacturing

Our facilities and expertise include world-class fermentation based manufacturing, along with fully integrated Research and Development, Quality and Engineering.