title: Industry perspective for biotech products.
abstract: This presentation, held at the Joint PDA/EMEA Virus Safety Forum, provided an industry perspective on virus safety for biotech products. After discussion of the various groups of biologicals for human use, the presentation focused on a specific group of biologicals, the cell-derived rDNA products. The current authority guidelines of this group of well-defined biotech products were discussed, and a representative case study addressing virus safety aspects was presented. Questions for discussion were raised which illustrated the need for discussion between regulators and industry concerning updated guidance for this group of biologicals.
authors.affiliation: Novartis Pharma AG, Technical Research & Development Quality Assurance, Basel, Switzerland. Annemarie.moeritz@pharma.novartis.com
authors.forename: A
authors.initials: A
authors.lastname: Möritz
mesh_terms: D000818:Animals; D000911:Antibodies, Monoclonal / Q000302:isolation & purification; D001688:Biological Products / Q000592:standards*; D001709:Biotechnology; D002460:Cell Line; D004274:DNA, Recombinant / Q000302:isolation & purification; D006801:Humans; D012449:Safety; D014780:Viruses / Q000302:isolation & purification
chemical_list: D000911:Antibodies, Monoclonal; D001688:Biological Products; D004274:DNA, Recombinant