PHARMACOLOGY & BIOTECHNOLOGY
During production of API’s, it is useful to monitor various parameters in situ during manufacturing. Various components can be checked in order to determine if the process is on track as expected. In biological manufacturing, insight can be known in real time as to the growth cycle of the organism. Certain recovery plans can be implemented if the reaction or growth is not optimal. If no technology is giving feedback in real time, lower yields and less active APIs can result.
Different levels of acetaminophen content in excipients can be monitored using Raman spectroscopy. The process involves building a calibration curve for on-line predictions to be used in real time. Feedback as to the process can be integrated into a DCS for closed loop control.
It is common that CHO (Chinese Hamster Ovary) cells are used as a source to manufacturing biological APIs. The cells are grown in bioreactors supplied with media, food sources and a proper pH environment in order to thrive. In situ monitoring with spectroscopic techniques can supply real values into glucose uptake and lactate production. These components monitored in real time give insight if the culture is alive and well or is not behaving as expected.
FAQ
Typical applications include white light interference for thin film analysis, UV absorption of proteins for quantitative analysis, colorimetry, impurity detection in water, cleaning validation for API manufacturing, polymerization inhibitor monitoring, electroplating bath monitoring....
The spectroscopic methodology is determined by which parameters are important to monitor during a process. For example, if you want to monitor protein concentration in a bioreactor, in which the biosynthesis takes place in an aqueous medium, then you likely would want to use Raman spectroscopy for the application, as water does not contribute to the Raman signal. Alternatively, if moisture content is important, water has very strong absorption in the NIR due to several vibrational and combination modes that can be monitored; water is transparent in the UV and visible spectral region. Understanding which chemical is important as there could be various factors that influence the choice of methodology....
NIR spectroscopy is utilized across a variety of industries for qualitative and quantitative product analysis. Typical industries include Chemistry, Pharmacology, Food Feed & Beverage, Agriculture, and others. NIR spectroscopy is well suited for species containing C-H, N-H & O-H bonds, making it a wide-range technology for a variety of applications such as moisture, fat, oil, alcohol, APIs, polymers, etc....
Raman spectroscopy is a technique which is used for several markets. These industries include Oil and Gas, Pharmacology, Biotechnology, Petrochemistry and many others. Due to the high selectivity of Raman spectroscopy, it is a powerful tool for many applications including, hydrocarbon analysis, bioreactor protein monitoring, crystallization monitoring, API concentration, polymer identification, surfactant analysis, natural gas components and several others....
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