title: Recent trends in cell substrate considerations for continuous cell lines.
abstract: Product development activity in the past five to ten years has reconstituted a version of an old debate on the safety assessment of biological products, namely whether the use of some types of continuous cell lines (CCLs) is appropriate in the preparation of some types of biological products. Since 1987, dozens of purified recombinant DNA products derived from CCLs have been developed and have received regulatory approval. In addition, several live attenuated and inactivated viral vaccines manufactured in CCLs were approved after thorough review of product safety and manufacturing issues. The current discussion revolves around the potential use of CCLs (human or not) to prepare purified protein subunit vaccines, such as for HIV, and the use of human CCLs to prepare purified protein products.
authors.affiliation: GlaxoSmithKline R&D, 709 Swedeland Road, 19406, King of Prussia, PA, USA. anthony.lubiniecki@sbphrd.com
authors.forename: A S
authors.initials: AS
authors.lastname: Lubiniecki
authors.forename: J C
authors.initials: JC
authors.lastname: Petricciani
mesh_terms: D000818:Animals; D001688:Biological Products / Q000592:standards* / Q000627:therapeutic use*; D002460:Cell Line; D004274:DNA, Recombinant / Q000235:genetics; D004335:Drug and Narcotic Control; D006801:Humans; D014765:Viral Vaccines / Q000592:standards / Q000627:therapeutic use
chemical_list: D001688:Biological Products; D004274:DNA, Recombinant; D014765:Viral Vaccines