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18.03.2021, Mainz, Germany
Enabling in-situ bioprocess monitoring using Raman spectroscopy with fully compatible systems from SCHOTT, INFORS HT, and tec5
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.”
This seamless combination of advanced and compatible PAT systems from SCHOTT, INFORS HT, and tec5 enables in-situ bioprocess monitoring and control using Raman spectroscopy. Photo: SCHOTT
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.
More information about SCHOTT ViewPort™
More information about tec5
More information about INFORS HT
Pioneering – responsibly – together.
These attributes characterize SCHOTT as a manufacturer of high-tech materials for specialty glass. Founder Otto Schott is considered its inventor and became the pioneer of an entire industry. Always opening up new markets and applications with a pioneering spirit and passion – this is what has driven the #glasslovers at SCHOTT for more than 130 years. Represented in 34 countries, the company is a highly skilled partner for high-tech industries: Healthcare, Home Appliances & Living, Consumer Electronics, Semiconductors & Datacom, Optics, Industry & Energy, Automotive, Astronomy, and Aerospace. In the fiscal year 2020, its 16,500 employees generated sales of 2.24 billion euros. With the best teams, supported by the best digital tools, the group intends to continue to grow. SCHOTT AG is owned by the Carl Zeiss Foundation, one of the oldest foundations in Germany. It uses the Group's dividends to promote science. As a foundation company, SCHOTT has anchored responsibility for employees, society and the environment deeply in its DNA. The goal is to become a climate-neutral company by 2030.
About INFORS HT
The story of INFORS HT began in 1965 with an unoccupied news kiosk in Basel. From those humble beginnings, the small family firm has developed into a global developer and manufacturer of cutting-edge incubation shakers, bioreactors, and bioprocess software. Many things have changed since our founding, but the uncomplicated culture of INFORS HT and our family atmosphere have stayed with us. The unorthodox ideas, open thinking, and creativity - pillars of our success – remain, as does our commitment to customer service.
To maintain our cutting edge, we follow industry trends and developments carefully. Our customers are our most important partners. We stay in close contact with institutions and companies around the world to develop the tools and technologies of the future.
Since 1993, the tec5 group has been developing and manufacturing high-quality, industry-standard systems, and components for process analytics. These specifically designed industrial spectrometer and photometer systems are used in a wide range of applications for incoming goods inspection, process control, and monitoring. Systems are engineered to be either integrated directly into production lines and vehicles or to be used as handheld devices.
tec5 thereby covers the entire technology chain for the development and production of the systems, setting standards in the flexible and rapid adaptation of the devices to meet individual process requirements and customer demands.
Throughout the whole design and implementation process, our team of expert engineers, scientists, and application specialists accompanies our clients from conceptual design, adaptation, engineering, to application support. Our customer service team is available for installation, training, and on-site service – planned and on-demand.
Press contact SCHOTT
PR & Communication Manager
Press contact INFORS HT
+41 (0) 61 426 98 35
Press contact tec5
The removable spectrometer probe is mounted with high positional accuracy and reproducibility to the SCHOTT ViewPort™ sensor receptacle. It spectroscopically measures the process medium in the bioreactor contactless via the hermetically sealed optical window. Next to laboratory scale, the use in production processes with stainless steel and single-use bioreactors is also possible. Photo: SCHOTT