Gas Analysis Mass Spectrometers have been used successfully for over 30 years on bacterial and microbial processes. More recently, there has been increasing interest in mammalian cell culture because they offer the prospect of radical advances in vaccines, monoclonal antibodies and gene therapy. Although the requirements of mammalian cell fermentation processes provide challenges to the off-gas analyzer, some mass spectrometers have already proved invaluable in improving understanding and increasing yields of mammalian cell cultures.
In a recently recorded webinar entitled “Real-time Bioprocess Monitoring of Mammalian Cell Cultures by Gas Analysis Mass Spectrometry,” Patrick Floris of the National Institute of Bioprocessing Research & Training (NIBRT) and I discussed our collaboration on a project to characterize different cell culture processes at NIBRT.
During the webinar we presented an overview of the implementation of Process Mass Spectrometry (MS) as Process Analytical Technology (PAT) for fermentation and cell culture. We then introduced two studies on the subject of PAT for bioprocess monitoring, and then reported the findings from a trial that took place at University College London, regarding process MS monitoring of mammalian cell culture processes. We also gave viewers an introduction to Mass Spectrometry technology and then answered questions from the audience.
NIBRT was interested in using mass spectrometry because of PAT principles. PAT guidance was introduced in 2004 by the FDA to promote the use of new measuring techniques aimed at gaining insights about influence of various Critical Process Parameters (CPPs) on product titre and quality. In-line and On-line solutions such as off gas analysis are ideal for implementing PAT principles as process data is acquired in real time. The benefit is that such understandings can improve process control and yield robust and reproducible processes.. Typical off-line and on-line measurements would not facilitate the development of such understandings.
- In-line measurements are obtained in-situ.
- On-line measurement techniques typically require modifications of bioreactor setups to divert a sample stream.
- Off-line and At-line analyses are characterized by discontinuous sample preparation, measurement and evaluation.
Watch the recording to learn more about Magnetic Sector MS for bioprocess monitoring, the bioreactor setup, systems used, how they were calibrated, assessment of bioreactor sterility, additional study details and results.
- Free ebook: A Practical Guide to Improving Pharmaceutical and Biotech Manufacturing Processes and Production Methods
- Visit www.thermofisher.com/PAT
- Additional application notes, white papers, and other free resources are available in the Improved Quality and Productivity for Pharma and Biotech Manufacturing section of our website.