title: Quantitation of DNA and protein impurities in biopharmaceuticals.
abstract: The development of drugs and biologicals for human injection generated from recombinant DNA and hybridoma technologies has resulted in new standards for product purity. We discuss the regulatory position relative to impurities in these biopharmaceuticals, focusing on the analytical goals for quantitation. Current methods for making these measurements are reviewed, and a new system designed for improved analysis is described. Assay results for both contaminating DNA and proteins are presented.
authors.affiliation: Molecular Devices Corporation, Menlo Park, California 94025.
authors.forename: J
authors.initials: J
authors.lastname: Briggs
authors.forename: P R
authors.initials: PR
authors.lastname: Panfili
mesh_terms: D002626:Chemistry, Pharmaceutical / Q000331:legislation & jurisprudence / Q000592:standards*; D004274:DNA, Recombinant / Q000032:analysis*; D010592:Pharmaceutic Aids; D004364:Pharmaceutical Preparations; D011786:Quality Control; D011994:Recombinant Proteins / Q000032:analysis*
chemical_list: D004274:DNA, Recombinant; D010592:Pharmaceutic Aids; D004364:Pharmaceutical Preparations; D011994:Recombinant Proteins