title: United States Pharmacopeia activities in the area of vaccines, virology and immunology.
abstract: The United States Pharmacopeia (USP) develops public standards for medical products that are enforceable by FDA. USP general information chapters have been providing industrial and academic researchers alike with crucial guidance especially in areas where there is absence of regulatory guidance. In an effort to meet the challenge of rapid advances in vaccine research and manufacturing, the Council of Experts Committee for Vaccines, Virology, and Immunology of the US Pharmacopeia has recently initiated two new general chapters to provide advice for researchers and manufacturers in the vaccine and virology fields and beyond. Chapter 1235 Vaccines and Vaccine Test Methods will focus on manufacturing and analytical requirements for the different types of vaccines currently in manufacture and development. Chapter 1237 Virology Test Methods will discuss modern diagnostic virology techniques and a variety of tests as applicable to vaccine and biologics manufacturing.
authors.affiliation: Department of Standards Development, United States Pharmacopeia, 12601 Twinbrook Parkway, Rockville, MD 20852, USA. tsm@usp.org
authors.forename: Tina S
authors.initials: TS
authors.lastname: Morris
mesh_terms: D000486:Allergy and Immunology / Q000592:standards; D001688:Biological Products; D001709:Biotechnology; D006801:Humans; D010602:Pharmacopoeias as Topic; D014481:United States; D014612:Vaccines / Q000592:standards; D014773:Virology / Q000592:standards
chemical_list: D001688:Biological Products; D014612:Vaccines