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EMEA offers advice on producing vaccines

This article was originally published in The Gold Sheet

Executive Summary

The European Medicines Agency recently issued a guidance that gives pointers on the manufacture of live recombinant viral vector vaccines. The guideline notes that different approaches are being used to create these vaccines and the design of the viral vector upon which the vaccine is based "is central to product development, manufacture and safety and efficacy." The guideline notes that "the production of a live recombinant viral vectored vaccine is likely to follow that of other live viral vaccines in that in many cases there will be minimal downstream processing and the basic requirements for manufacture and control will be essentially similar … the method of production will involve the growth of the vaccine virus in the production cell line/substrate. Depending on the scale of production, it may be necessary to expand an ampoule of working seed before inoculation of the production cell culture." In addition, manufacturers should ensure that diluents, stabilizers or other types of excipients added during preparation of the final bulk vaccine not impair the safety and efficacy of the vaccine. The guidance updates a 2001 version that it said had provided "insufficient regulatory guidance" and had relied on outdated scientific principles. The deadline for comment is Nov. 30
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