In addition to enzymes, our team has supported development programs during scale up and manufacture of proteins, antibody fragments and carbohydrates.
Process Transfer follows four steps:
- Feasibility (technical and commercial)
- Process Transfer, which covers reproducing the current process, focusing on critical control points
- Process Development, including Design of Experiment (DOE), upstream and downstream optimization, and Pilot production
- Commercial Manufacture, which addresses Engineering, Validation, and Quality Assurance requirements
Our facilities and expertise include world-class fermentation based manufacturing, along with fully integrated Research and Development, Quality and Engineering.
Committed to operating to the highest quality standards.
- Compliant with ISO 9001 all operations certified
- OHSAS 18001 Safety Management System
- ISO 14001 Environmental Management System
- FDA 21 CFR 820.30 GMP operations available for therapeutic manufacturing
- ISO13485 plus other controlled processes (suitable for Biopharma processing)