Mammalian Cell culture technology is the primary means of manufacturing biotherapeutics including monoclonal antibodies. There are a variety of biotherapeutics that are produced in small and large-scale processes. This can be for the purposes of development, clinical studies, or the production of marketed products.
Federal regulatory bodies are recommending the use of reliable Process Analytical Technology (PAT) to ensure the reliability of their processes. Process Analytical Technologies provide feedback while the process is running, allowing for real-time adjustments to ensure quality. This includes upstream cell culture manufacturing processes. This has driven companies operating in Current Good Manufacturing Practice (cGMP) environments to look into the integration of Raman as a PAT tool in order to comply with the recommendations and quality expectations.
Raman spectroscopy technology is an ideal tool for upstream PAT as it has been shown to facilitate the monitoring of several important CQAs within mammalian cell cultures. Therefore it provides an important means of monitoring and/or controlling bioprocesses. The following are some examples of CQAs of interest for Raman measurements with Tornado’s Raman spectroscopy-based analyzers:
- Viable Cell Count and Total Cell count (VCC and TCC)
- Protein titer
- Glutamine, Glutamate, and other amino acids