What are the current challenges in bioprocess monitoring and how we can we overcome them?
Today, many pharmaceutical manufacturing processes are monitored by taking physical samples to a laboratory for analysis. This is not only laborious, but the results represent only a single moment in time. Because taking samples requires opening the bioreactor, there is also a risk of losing the entire batch due to contamination. Thanks to the ongoing development of new technologies, such as Raman spectroscopy, continuous monitoring methods can now be used to observe key parameters in real time. This allows problems to be caught early and process parameters to be adjusted to optimize quality, throughput, and yield.
Kristina, what is Raman spectroscopy?
Raman spectroscopy is one type of analytical technique used in the life sciences to identify the molecules in a sample. It works by illuminating a sample with visible or near infrared laser light, which triggers molecular vibrations. These vibrations can be used to determine the chemical composition of a sample – the so-called chemical fingerprint – and other vital material properties such as molecular concentration.
What are the benefits of Raman spectroscopy?
Oh, there are many benefits. The light-based nature of Raman spectroscopy makes it a non-destructive and non-contact way to perform measurements. It also requires little handling or preparation of samples, produces quick results, and supports automation. Raman spectroscopy’s high molecular specificity means it works well even with non-homogenous compositions.
In addition, Raman analysis can be used in a great variety of possible applications. The technology has matured to a point where measurements using light can be performed contactless through glass windows or fiber optics or inside test tubes. It is even possible to use it with aqueous solutions. This versatile technique can be used to confirm the purity of raw materials, validate mid-process composition, or perform final product checks. This analysis can be performed using existing standard ports on laboratory to production-scale bioreactors.
How does SCHOTT facilitate the application of Raman spectroscopy?
Our ViewPort® process analytical technology (PAT) components are revolutionary ports that act as a sterile-safe interface between optical measurement systems, such as Raman spectrometers, and bioreactors. This allows bioprocess monitoring to be performed through hermetically sealed optical windows without compromising the sterile boundary.
What are the advantages of using a ViewPort® interface?
With ViewPort® components, the risk of losing a batch due to contamination is greatly reduced compared to taking physical samples. Moreover, these interfaces reduce the number of parts requiring sterilization. The ViewPort® technology also allows optical instruments, including spectrometers, to be exchanged during the running cultivation or shared between bioreactors, and the ports can be shared with additional optical tools. This reduces the need for redundant instruments, thus lowering costs. Our portfolio also includes ports that can be incorporated into single-use bioreactor bags for future innovation in process analysis.
Six steps for an advanced non-invasive, sterile integration of Raman probes