Fermentation Control in Pharmaceuticals, Life Science and Biotechnology

Fermentation, a process critical to pharmaceuticals, life science, and biotechnology, involves the growth of bacteria and the production of drugs. It consists of three stages: primary fermentation, secondary fermentation, and bottle or keg conditioning and carbonation. This process is widely used to produce biomass, enzymes, chemicals, and pharmaceuticals. Traditionally, yeast, fungi, and bacteria have been the primary cell types used in fermentation.

The fermentation process is a complex biological mechanism that converts organic materials, such as sugars, into valuable products like biofuels, pharmaceuticals, and biopolymers. To enhance the efficiency and quality of this process, monitoring key parameters in real-time is essential. This is where mass spectrometry plays a crucial role in pharmaceuticals, life science, and biotechnology.

Our EXTREL™ Quadrupole Mass Spectrometer provides fast, precise, and comprehensive analysis of both incoming air and off-gases from the fermenter. The data collected helps calculate the Respiratory Quotient (RQ), a critical parameter for controlling bacterial growth and health. As fermentation progresses, the RQ value fluctuates, allowing for optimized and efficient drug production. Furthermore, analyzing trace concentrations of by-products facilitates rapid process adjustments, preventing undesired reactions.

To further optimize fermentation processes in pharmaceuticals, life science, and biotechnology, we recommend our MGA™ Fixed Magnetic Sector Mass Spectrometer. This instrument analyzes gas samples to monitor and control the fermentation process effectively. It detects and quantifies a wide array of gases, including carbon dioxide, oxygen, nitrogen, and other volatile organic compounds (VOCs). By monitoring metabolic activity, measuring nutrient uptake, and detecting contamination, the mass spectrometer helps maintain process integrity.

Additionally, our solutions include:

• Benchtop Mass Spectrometer for real-time multi-stream bioreactor control: MAX300-LG™
• CRDS Single-Species Trace Gas Analyzer for detecting trace levels of H2O, CH4, CO, CO2: Spark™

Process Analytical Technologies (PAT) in Pharmaceuticals, Life Science and Biotechnology

Process Analytical Technologies (PAT) is a strategy employed in manufacturing and process industries to monitor and control production in real-time. By utilizing advanced analytical techniques, PAT ensures that process parameters are continually monitored to guarantee that products are consistently manufactured to meet the desired quality standards in pharmaceuticals, life science, and biotechnology.

Our quadrupole mass spectrometers are instrumental in detecting even trace amounts of impurities or reaction intermediates. These instruments provide real-time feedback to the process control system, allowing for immediate adjustments. For instance, process parameters such as flow rate or temperature can be fine-tuned to optimize the process and ensure consistent product quality.

Moreover, our MGA™ Fixed Magnetic Sector Mass Spectrometer is a powerful analytical tool for a wide range of PAT applications. This mass spectrometer is particularly beneficial for pharmaceuticals, life science, and biotechnology due to its exceptional accuracy and precision. It can detect and quantify trace chemical species with remarkable sensitivity and specificity, making it ideal for real-time monitoring. Its ability to provide precise measurements across various chemical species makes it a key tool for ensuring process efficiency and product consistency in these sectors. Thus, its role in process monitoring and control cannot be overstated.