Influence of the cellular host-vector system on the quality of therapeutic proteins obtained by recombinant DNA...

Variability of biologicals produced by genetic engineering should be controlled at the level of gene isolation, vector and clone (animal or bacterial) construction, translation and post-translational modifications and purification. In addition to the traditional tools of analytical chemistry of proteins the techniques of nucleic acid analysis such as Southern and Northern blot, RNase A cleavage and DNA sequencing must be used to control stability of genetic constructs, from the start to the end of the production process. Analytical protocols to establish authenticity of proteins should consider the bacterial or animal origin of the product, with special emphasis on techniques that allow determination of sugar content and structure.