Guidelines for the acceptability, management and testing of serially propagated human diploid cells for the production of live virus vaccines for use in man

Serially propagated human diploid cells (HDC) have been used extensively for a number of years for the production of live virus vaccines and other biological products for human use. The requirements recommended at present by the United Kingdom Licensing Authority for the acceptability of these cells and for monitoring them when used to produce live-virus vaccines are based on criteria proposed by the Committee on Cell Cultures of the Permanent Section of Microbiological Standardization (Minutes, 7th Meeting Cell Culture Committee, 1970). These requirements have remained essentially unchanged for the past decade. However, in the light of experience gained from long-term studies of the characteristics of the cells and their control, these requirements have been reviewed and modified. They are published for the information of national authorities concerned with the licensing and control of products associated with the use of HDC substrates and of those concerned with the production of viral vaccines intended for use in man.