title: Regulatory perspective in the United States on cell cultures for production of inactivated influenza virus vaccines.
abstract: The United States Code of Federal Regulations requires that all influenza virus vaccines produced for use in the United States adhere to specific regulatory standards including the demonstration of safety and efficacy. For vaccines produced in cell lines, rigorous characterization for manufacturing is particularly important. Influenza vaccines produced by the passage of viruses in mammalian cell lines will require careful evaluation to ensure the removal or inactivation of potential adventitious agents.
authors.affiliation: Division of Viral Products, Center for Biologics Evaluation and Research, Rockville, MD, USA.
authors.forename: R A
authors.initials: RA
authors.lastname: Levandowski
mesh_terms: D000818:Animals; D018929:Cell Culture Techniques / Q000592:standards*; D006801:Humans; D007252:Influenza Vaccines / Q000592:standards*; D011640:Public Policy; D014481:United States; D015164:Vaccines, Inactivated; D014776:Virus Cultivation / Q000592:standards*
chemical_list: D007252:Influenza Vaccines; D015164:Vaccines, Inactivated