title: Quality assurance of products manufactured by recombinant DNA technology. A European inspector's reflections.
abstract: Rapid and continuous progress in biotechnology is leading industry to increasing application of recombinant DNA (rDNA) technology in the production of drug substances. The main motives are obtaining products in larger amounts and better quality by means of comparably economical methods. For reasons of safety and purity some national regulatory agencies are excluding drug substances of natural origin, e.g. human growth hormone isolated from pituitary glands, where the same products obtained by rDNA are available. General and specific literature on biotechnology is widely available but official guidelines and regulatory requirements for registration, manufacture and control of pharmaceuticals produced by rDNA are still exceptional. In Switzerland the experience in the field of rDNA-based large scale production of pharmaceuticals is limited. The registration of the preparations and the inspection of their industrial production therefore take place on a case by case basis. For that purpose the relevant "Points to consider" issued by the American Food and Drug Administration (FDA) are essential. A comparison between conventional manufacture and rDNA technology is made by indicating some examples.
authors.affiliation: Intercantonal Office, Control of Medicaments, Berne, Switzerland.
authors.forename: T
authors.initials: T
authors.lastname: Witschi
mesh_terms: D004247:DNA / Q000378:metabolism; D005060:Europe; D011786:Quality Control; D011994:Recombinant Proteins / Q000032:analysis / Q000592:standards*
chemical_list: D011994:Recombinant Proteins; D004247:DNA