Applications biotechnological process monitoring

Within the last few years FIA has found increased application in process monitoring, such as in biotechnology. A common feature of these procedures is that they require (a) representative samples to be drawn from a process solution and (b) the samples have to be purified from... 

A similar system, the "concertation procedure" is already in place and is obligatory for products from biotechnological processes. The CPMP becomes involved as soon as the first application in any member state is lodged. One country s agency acts as rapporteur and prepares a full evaluation report, other countries provide "monitoring reports". Based on these reports and the expert reports in the dossier, the CPMP summarizes its assessment in an opinion report which is considered by the national authorities, before they make their decision. 

Ibble Z2-1. Applications of biosensors for process monitoring in biotechnology (CD calibration data only, no on-line monitoring data). 

Hosobuchi, M., Kurosawa, K. and Yoshikawa, H. (1993) Application of computer on monitoring and control of fermentation process microbial conversion of ML-236B sodium to pravastatin. Biotechnology and Bioengineering, 42, 815-820. 

This is the consequence of the traditional application of CE in the process and product monitoring of rDNA-derived biopharmaceuticals in biotechnological industries. However, related proteins, and dimer and related substances of higher molecular mass of somatropin, and aprotinin are evaluated by means of HPLC and size exclusion chromatography, respectively, by the EP. 

It is a method of elemental analysis for various practical reasons and it is essentially suitable for analysis only of metals. A large number of elements can be analyzed for at trace levels. Therefore, its biotechnologic applications mainly involve in measurement of inorganic elements such as alkali, trace, and heavy metals in biological investigations. It is also used in industry to monitor contaminating inorganic elements in bioreactors fermentation process and preparation of culture media. 

HPLC on a 2.1mm column at 400 til min-1 flow. Two drugs are monitored by selected ion monitoring. Left 400 pi min-1 is injected in the source. Centre 132 almin-1 is split to the source. Right 15 pi min-1 is split to the source. The integration values are displayed on top of the peaks and show that at reduced flow rates the sensitivity is slightly increased. Reproduced with data from Covey T., Analytical Characteristics of the Electrspray Ionization Process pp. 21-59 in Biochemical and Biotechnological Applications of Eletrospray Ionization Mass Spectrometry Snyder A.P., ed., ACS Symposium Series 619, American Chemical Society, 1996. 

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