PHARMACOLOGY & BIOTECHNOLOGY

Equipment Applications for Pharmacology-Lyophilization

Lyophilization

Lyophilization is widely used in the production of biological materials.  The procedure is done to stabilize proteins for long term storage or to prevent degradation of biological samples. It is a freeze drying procedure that results in proper solvent levels for longer shelf life.  Analysis of the solvent levels is usually done in a lengthy laboratory procedure.  Implementation of NIR technology can result in the same data in a non-destructive manner. 

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Lyophilization

Lyophilization is performed to preserve enzymes or medicine to extend shelf life and/or stability before use. During manufacturing it is imperative to keep solvent levels appropriate in the final product. Solvent level determination is done in a destructive laboratory procedure and does not necessarily represent the whole lot of vials.

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Laboratory Destructive Analysis

A Karl-Fischer analysis is done in the lab in order to get moisture levels on lyophilized samples. This is a destructive technique and is not always representative of each sample. Usually a survey of samples are analyzed to get an idea of what the solvent level is in the lot.  The analysis takes time and error can be technician dependent.

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Non-Destructive NIR Analysis

NIR spectroscopy can be used to interrogate moisture or solvent levels in a sample non-destructively. The sample is presented to the spectrometer through the bottom of the vial and analyzed. A number is generated from a calibration curve which resides on the instrument. The analysis can take less than 30 seconds, much faster than labor intensive techniques such as Karl Fischer.

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Calibration Curves

Calibration curves are built using primary techniques. This process is usually done one time for each product of interest. The predictions are done automatically and present a value to the user within a minute.

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    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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