A comprehensive process analytical technology (PAT) solution is ready for pharmaceutical companies to further enhance automation and real-time monitoring of their bioprocesses without compromising the sterile boundary. International technology company SCHOTT, biotech manufacturer INFORS HT, and the process spectrometer manufacturer tec5 are announcing a highly advanced product combination for the direct use of Raman spectroscopy in bioreactors. The tailored system is a seamless combination of bioreactor, spectrometer system, and probe receptacle, and meets typical instrumental and regulatory requirements.
With the industry moving from traditional and fed batch manufacturing to continuous processing of biopharmaceuticals, analytical methods are becoming increasingly important to offer consistent and reliable productivity in terms of process safety and product quality. Combining their expertise and complementary components, SCHOTT, INFORS HT, and tec5 are advancing Raman spectroscopy as an in-line measuring technology in bioprocesses. Speaking on behalf of the companies, Christian Ott, Manager R&D Biotech from SCHOTT adds, “Together, we’re enabling the use of Raman spectroscopy in bioreactors. The unique combination of advanced PAT solutions allows for reliable in-line process monitoring and control.”
The innovative PAT system was designed to:
- Prevent contamination and optimize yield by enabling pharmaceutical companies to measure relevant chemical and physical parameters in-situ without the need to open the bioreactor for sampling.
- Enable real-time process control and automation by capturing increased physical and chemical parameters to identify anomalies by real-time monitoring. Deviations in the process flow can therefore be identified in real time and directly adjusted in terms of process control.
- Conveniently integrate sensors into bioprocesses. Thanks to the standardized interfaces, the adaptation of the measuring devices to the bioreactors is easy and safe. Changing the measuring points is also possible without difficulties.
The successfully tested system includes the bioreactor Minifors 2 and bioprocess software eve® from INFORS HT – the latter enabling users to centralize all bioprocess data in one database. Thus, advanced control strategies can be deployed for bioprocesses while being continuously developed for the integration of additional sensors. Attached to the bioreactor port is the sterile optical sensor receptacle SCHOTT ViewPort™, made by optical glass and glass-to-metal sealing expert SCHOTT. It features a hermetically sealed optical window made of sapphire for in-situ process monitoring with optical sensors. Dedicated Raman spectrometer systems from tec5 have been specifically adapted to perfectly fit the different variants of SCHOTT ViewPort™.
For chemometric method development, the system is compatible with established software solutions for multivariate data analysis. For an easy introduction to the technology, validated calibration models for common applications are in preparation.
Simplified, user-friendly operation under sterile conditions
The SCHOTT ViewPort™ sensor receptacle can be attached to standard bioreactor ports, such as an ingold or PG13.5. The bioreactor and integrated SCHOTT ViewPort™ can then be sterilized as usual using γ-radiation or steam-in-place (SIP). Finally, the spectrometer probe is mounted with high positional accuracy on the SCHOTT ViewPort™ components during operation using a quick-release fastener. It is also easy and safe to change the probe between different ports. All components are manufactured using materials in accordance with pharma industry best practices, making the system ideally suited for use in regulated areas, such as Good Manufacturing Practice (GMP) and hygienic design.