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.

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.

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