Services
Technology Transfer includes:
- Process Feasibility Assessment:
- Technical and commercial evaluation of process fit to facility and equipment
- 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
- Process and Analytical Development:
- Design of Experiment (DOE)
- Upstream and downstream optimization
- Pilot scale production
- 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
- 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.
Technology Transfer includes:
- Process Feasibility Assessment:
- Technical and commercial evaluation of process fit to facility and equipment
- 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
- Process and Analytical Development:
- Design of Experiment (DOE)
- Upstream and downstream optimization
- Pilot scale production
- 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
- 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.