Thermo Fisher Scientific and SIEMENS Combine Industry Leading Technologies for Advanced PAT Applications
Thermo Fisher Scientific Inc., the world leader in serving science, has combined the Thermo Scientific Antaris family of FT-NIR analyzers and SIEMENS SIPAT™ software platform to provide a comprehensive solution for advanced process understanding and continuous control and improvement in drug development and manufacture.
The integration is a natural extension of the Antaris™ analyzer product line, and is designed to allow pharmaceutical companies to further extend the capabilities of the FT-NIR analyzers to achieve better process insight, real-time product release, improved manufacturing performance and enhanced quality while maintaining regulatory compliance. This initiative creates a solution tailor-made to the needs of the pharmaceutical industry that seamlessly migrates process analysis from the laboratory into production, effectively mitigating risk and is intended to drive significant cost-savings.
“We believe that the collaboration between SIEMENS and Thermo Fisher Scientific represents a great step forward in advancing process control in the pharmaceutical industry,” said Dr. Jeffrey Hirsch, NIR product manager, Thermo Fisher Scientific. “The Antaris portfolio of FT-NIR analyzers has a proven track record of robust, precise analysis in rugged environments allowing for real-time decisions that maximize yield and grow the bottom line. By combining these world leading technologies, we are able to facilitate more cost-effective and streamlined PAT implementation projects.”
All of the Antaris FT-NIR analyzers are built from the ground up to suit the specific requirements of the pharmaceutical industry. They include internal calibration standards which allow instrument qualification without having to stop the process or remove the probe from the culture media. With features like a flex-pivot interferometer and pinned-in-place optics inherent in the analyzers, each scan of the samples is the same as the last one providing accurate, precise and reliable measurements. SIPAT is SIEMENS’ software that supports PAT implementation, acquiring data from multiple analyzers and other data sources.
SIPAT enables process understanding and continuous process improvement in both manufacturing and development. It also supports (advanced) process control whereby it can either focus on specific units or cover total batch quality to enable real-time product release. SIPAT facilitates improved and faster product development and shortens time-to-market.