Bioprocess Knowledge at the Speed of Light
Stratophase are innovators in biopharmaceutical in-line monitoring of glucose status, enabling real time process control.
“PAT gives increased understanding and control of the manufacturing process, offering potential economical and environmental benefits associated with improved yields, and reduced waste and energy consumption.”
— Centre for Process Innovation, UK, Oct 2010
“The key objectives of PAT and QbD are to increase consistency and quality of biological products, reduce production times, and prevent batch rejection. A key to achieving this, is the real-time, in-line monitoring of critical parameters in the manufacture process, rather than testing the end product”
— Guidance for Industry PAT U.S. Department of Health and Human Services FDA, September 2004
