title: Glycoconjugate Vaccines: The Regulatory Framework.
abstract: Most vaccines, including the currently available glycoconjugate vaccines, are administered to healthy infants, to prevent future disease. The safety of a prospective vaccine is a key prerequisite for approval. Undesired side effects would not only have the potential to damage the individual infant but also lead to a loss of confidence in the respective vaccine-or vaccines in general-on a population level. Thus, regulatory requirements, particularly with regard to safety, are extremely rigorous. This chapter highlights regulatory aspects on carbohydrate-based vaccines with an emphasis on analytical approaches to ensure the consistent quality of successive manufacturing lots.
authors.affiliation: Laboratory for Molecular Structure, National Institute for Biological Standards and Control, Blanche Lane, South Mimms, Potters Bar, Hertfordshire, EN6 3QG, UK, chrisjones715@btinternet.com.
authors.forename: Christopher
authors.initials: C
authors.lastname: Jones
mesh_terms: D002460:Cell Line; D006001:Glycoconjugates / Q000276:immunology* / Q000592:standards*; D006801:Humans; D007223:Infant; D014612:Vaccines / Q000276:immunology* / Q000592:standards*
chemical_list: D006001:Glycoconjugates; D014612:Vaccines