Improve biotech processes with mass spectrometry gas analysis
What if you could achieve faster off-gas composition analysis without sacrificing precision and quality? With our Prima mass spectrometers, you can. As the standard in gas analysis, our robust instruments provide improved precision, accuracy, long intervals between calibration, and resistance to contamination, so you can optimize industrial processes across many applications – from biopharma to biofuels.
Thermo Scientific 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, our mass spectrometers for bioreactor monitoring have already proved invaluable in improving understanding and increasing yields of mammalian cell cultures.
In mammalian cell fermentations, the feed gas composition is a frequently changing mixture of several compounds. The feed gas concentration ranges also vary dramatically. The implementation of real-time, off-gas analysis using Mass Spectrometry in mammalian cell culture can help identify process deviations during bioreactor runs and evaluate batch to batch variation, within predefined specifications, for robust manufacturing.
Laboratory quality gas analysis for fermentation processes
Analysis of respiratory gases is an ideal way of fermentation monitoring. It’s non-invasive and provides invaluable information on the physiological state of the culture, including growth kinetics and substrate consumption. It also helps determine the optimum point to halt the process for maximum yield. Many fermentations are characterized by small changes in oxygen and carbon dioxide concentrations. The speed of our Thermo Scientific Prima PRO Process Mass Spectrometer makes it ideal for fermentation process control, but speed must not be at the expense of precision. It is equally important that precise data is acquired; otherwise, small changes in concentration will be lost.
Over 30 years of industrial experience have shown that magnetic sector analyzers offer the best performance for fermentation off-gas analysis. Key advantages include improved precision, accuracy, long intervals between calibration, and resistance to contamination. Typically, analytical precision is between 2 and 10 times better than a quadrupole mass spectrometer.
Use magnetic sector mass spectrometry to control the solvent drying process with fast, precise, quantitative data
A key stage in many pharmaceutical processes is the complete or partial removal of a solvent or solvents from a product or intermediate. This solvent recovery process can occur in a variety of process vessels, including vacuum dryers, tray dryers and rotary dryers.
In the past, the success of the solvent drying process was simply measured at the end by taking a sample for laboratory analysis and the amount of residual solvent was defined by the Loss on Drying (LOD). If the sample failed the LOD test for one or more of the solvents then the drying process had to be restarted. If the drying took place under vacuum this provided additional complications in terms of both sampling the active pharmaceutical ingredient (API) and re-starting the dryer.
Mass spectrometers have been used to monitor solvent levels in the headspace above the API during drying processes but they have typically only produced qualitative or semi-quantitative data. If the Prima PRO Process Mass Spectrometer is to be used as part of a PAT solvent drying process control project, it must produce accurate, reliable quantitative data, even for multi-dryer, multi-solvent systems.
Thermo Scientific GasWorks Process MS software provides the unique and powerful interface for the Thermo Scientific Prima PRO, Prima BT, Sentinel PRO and APIX δQ Mass Spectrometers. The software has been designed to ensure that the process analyzer is simple to configure, operate, and maintain without any prior mass spectrometer experience for better process analytics.
The suite includes a wide range of functions and features. Whether the requirement is for a simple alarm indication in the event of a manufacturing process failure, or for complex data presentation for process understanding and control, Gasworks Software is well equipped to offer an effective solution.
- Supports stand-alone analyzer operation
- Sets no limits to the number of sample streams or analytical methods
- Includes rigorous mathematical equations to deconvolute complex mixtures
- Multi-layered security with expiring passwords and audit trail
- Supports the integration of third-party analytical data
Pharmaceutical & biotech manufacturing processes & production methods
Process Analytical Technology (PAT) is a regulatory framework initiated by the United States Food and Drug Administration (FDA) that encourages pharmaceutical manufacturers to improve the process of pharmaceutical development, manufacturing, and quality control.