Reduced Contamination Risk and Higher Process Yield in Bioreactors.
Biopharmaceutical processes require reliable analytical methods to ensure product safety, quality and productivity. However, conventional methods depend on opening the bioreactor when extracting a sample or compromising the sterile boundary when inserting a probe, which increases the risk of contamination. With SCHOTT ViewPort™ process analytical technology (PAT) components, continuous in-situ measurement is possible without penetrating the bioreactor barrier. The metal conduit, which acts as a receptacle and optical interface for sensors or spectrometers, features a tightly sealed optical window consisting of sapphire, which enables real-time process monitoring. The components are developed and manufactured by the optical glass and glass-to-metal sealing expert SCHOTT in Germany, and are available as standard variants for multi-use bioreactors (MUB) as well as customized versions for single-use bioreactors (SUB).
When it comes to public health, pharmaceutical drugs such as vaccines play a key role. To develop these drugs, pharma companies need to enable both safe and efficient pharmaceutical manufacturing processes. “Our goal was to improve current bioprocess control systems, which led to the development of the revolutionary PAT components, namely SCHOTT ViewPort™ receptacles,” explains Christian Ott, Manager R&D Biotech at SCHOTT.
Reducing contamination risk
The components enable safe and sterile in-situ process control through highly transmissive optical windows. “Instead of having to open the bioreactors, pharma companies can now monitor the inside chemical and physical parameters from the outside without compromising the sterile boundary. This can significantly reduce the risk of cell culture contamination and increase process yields,” adds Ott.
Enabling advanced measurement technologies
On-line spectroscopy and other optical sensors are able to further improve bioprocess monitoring. By integrating sterilizable SCHOTT ViewPortTM receptacles on bioreactors, pharma companies can use advanced optical sensing technology for reliable and automated analysis. This supports safety, yield, and automation level of bioprocesses as even small deviations can be detected at an early stage and adapted.
SCHOTT is collaborating with the renowned spectroscopy manufacturer tec5 to offer compatible user-friendly systems, consisting of the spectroscopy module from tec5 and the SCHOTT ViewPortTM sensor receptacle.
Small component Big improvements
SCHOTT ViewPort™ was designed to:
• Enable safe and sterile processes by enabling in-situ measurement through hermetically sealed optical windows without having to open the bioreactor for physical sampling.
• Increase process yield with continuous real-time measurement while preventing contamination through sample taking.
• Enable process automation by collecting more physical or chemical parameters to detect abnormalities with real-time monitoring and enabling advanced process analytical technology to adapt the key process parameters if required.
From lab-scale to large-scale
SCHOTT ViewPort™ is suitable for bioreactors of varying sizes and includes a standard port diameter and flange size for easy integration into existing systems and designs. A secure connection to ingold as well as other standard and customized ports of bioreactors further enables an easy sterilization process, such as steam-in-place (SIP) of the bioreactor, including the integrated SCHOTT ViewPort™.” SCHOTT’s PAT components are manufactured using materials according to pharma industry best practices. These include premium steel, glass, sapphire, and polymer, and feature an individual code for supporting GMP requirements. Moreover, one spectrometer can be used to monitor multiple bioreactors for enhanced cost and time efficiency.
SCHOTT (schott.com) is a leading international technology group in the areas of specialty glass, glass-ceramics and related high-tech materials. With over 130 years of experience, the company is an innovative partner to many industries, including the home appliance, pharma, electronics, optics, life sciences, automotive and aviation industries. SCHOTT has a global presence with production sites and sales offices in 34 countries. In the 2018/2019 fiscal year, the group generated sales of around $2.54 billion with over 16,200 employees.