The US FDA wants to boost the production of cell-based viral vaccines and says new guidance will help manufacturers.
While the H1N1 pandemic may not be as severe as first thought, the difficulty drugmakers faced in trying to build vaccine stockpiles using egg-based production methods did highlight the need for new manufacturing technologies.
And beyond influenza, while cell cultures are now used to produce licensed vaccines against diseases such as rubella and polio in general the pharmaceutical industry has been slow to adopt such methods.
Part of the reason for this is that selecting the most appropriate cell line to use can be a very complex process, particularly for manufacturers new to the field who may be unprepared for the sheer number of production variables involved.
The US Food and Drug Administration (FDA) believes its new guidance document, available here , can make it more straightforward for vaccine makers to use cell culture methods, and accelerate production.
The guidelines cover the characterisation and qualification of the mammalian and insect cell substrates used in vaccine production as well as some of the technical hurdles to be overcome in this type of manufacturing.
Topics include methods used to measure vaccine purity or identify potential sources of contamination, through to good manufacturing practice requirements and the appropriate use of control cultures.
The agency explained it developed the guidance after a decade long research programme to outline “best practices using current and emerging science to safely expand the types of cells that may be used to produce vaccines.”
The Food and Drug Administration (FDA) added that the information supplements the recommendations already detailed in International Conference on Harmonization (ICH) documents Q5A and Q5.
Agency Commissioner Margaret Hamburg said: “The availability of this final guidance is an important tool to help manufacturers advance the development and production of cell-based vaccines against infectious diseases.”