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BIOforum. 1993; 11: 400-406.

Quantitative PCR DNA trace analysis in recombinant proteins

By: Merz B, Jacobowsky B, Hötten G, Neidhardt H

The Polymerase Chain Reaction which enters into the 10th year of application in molecular biology represents a powerful tool in research and diagnostics. It can as well be used in the quality control of medicinal products to quantify residual burden of cell line-DNA due to the fermentation process of recombinant biologicals. Different authorities published recommendations concerning the limits of DNA contamination in biologicals. These limits which are situated in the range of 10-100 picograms require a sensible quantification method which can be used in the analysis of pharmaceuticals. In the development of a quantitatively operating PCR method the primer design and the construction of an internal standard molecule is essential. Chinese hamster ovary cell (CHO) DNA was used as a potential contaminant of the protein erythropoetin (EPO) in the examinations. For the mentioned system a sensibility of less than 10 pg was achieved with a quantitative PCR method.

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