Views on the issues raised in recent letters by Galibert recommending studies for genetic stability testing of cells used to manufacture purified polypeptide pharmaceutical products utilizing recombinant DNA (rDNA) technology. Committee on Process Development and Manufacturing.
D004274:DNA, Recombinant; D004355:Drug Stability; D005821:Genetic Techniques; D016296:Mutagenesis; D009154:Mutation; D010455:Peptides / Q000737:chemistry* / Q000235:genetics*; D011506:Proteins / Q000737:chemistry* / Q000235:genetics*; D011994:Recombinant Proteins / Q000737:chemistry*
D004274:DNA, Recombinant; D010455:Peptides; D011506:Proteins; D011994:Recombinant Proteins