Process control biotechnology-derived products

Capillary electrophoresis (CE) is a modern analytical method that is being extensively applied to the characterization of biotechnology-derived products like peptides and proteins [1], Due to its ease of automation and facilitating the development of reproducible routine analysis, CE seems to be well suited for the quality control of biotechnological products, including process monitoring, purity assessments. 

Committee for Proprietary Medicinal Products (1991). EEC Regulatory Document Note for Guidance Production and quality control of cytokine products derived by biotechnological processes. Biologicals 19, 125-131. 

Production and quality control of cytokine products derived from biotechnological processes (2/1990)... 

Increasing registration requirements for the product and the production process as well as environmental issues also add a significant technical and analytical dimension to the development. This particularly applies to products derived from biotechnology. Compared to conventional biological products, the final product is usually much better defined and its manufacturing process can be better controlled. But it requires the application of a variety of quite sophisticated techniques to do so. 

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