PHARMACOLOGY & BIOTECHNOLOGY

Equipment Applications for Biotechnology-Downstream processing

Downstream processing is the area where proteins or biological products are concentrated, purified, and prepared for final packaging.  It involves several chromatography and finishing techniques as the final product is stabilized for shipment. 

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Methodology

Downstream processing is the phase of biomanufacturing that yields a purified API from cell growth in a bioreactor. The cell culture harvested from a bioprocess is purified through various chromatography methods, finished and appropriately concentrated for final formulation and packaging in this area of production.

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Formulation

A final API concentration is determined for proper distribution into packaging. As a last prepatory step, UF/DF (ultrafilteration/diafilteration) is done to prepare the product with the proper buffers and stabilizers for long term storage and distribution.

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    FAQ

    Frequently Asked Questions at tec5USA

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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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