Considerations for setting the specifications of vaccines.
The specifications of vaccines are determined by the particular product and its method of manufacture, which raise issues unique to the vaccine in question. However, the general principles are shared, including the need to have sufficient active material to immunize a very high proportion of recipients, an acceptable level of safety, which may require specific testing or may come from the production process, and an acceptable low level of contamination with unwanted materials, which may include infectious agents or materials used in production. These principles apply to the earliest smallpox vaccines and the most recent recombinant vaccines, such as those against HPV. Manufacturing development includes more precise definitions of the product through improved tests and tighter control of the process parameters. Good manufacturing practice plays a major role, which is likely to increase in importance in assuring product quality almost independent of end-product specifications.
Division of Virology, National Institute for Biological Standards and Control (NIBSC)/Health protection Agency (HPA), Blanche Lane, South Mimms, Hertfordshire, EN6 3QG, UK. firstname.lastname@example.org
SourceExpert review of vaccines 11:5 2012 May pg 579-85
Clinical Trials as Topic
Guidelines as Topic
World Health Organization
Pub Type(s)Journal Article