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ja zāles sastāv no virālajiem vektoriem, izejvielas ir komponenti, no kuriem iegūts virālais vektors, proti, pamatvīrusa vektora sēkla vai plazmīdas, ko izmanto iesaiņojumšūnu transfekcijai, un iesaiņojumšūnu līnijas pamatšūnu banka.
in the case of products consisting of viruses or viral vectors, the starting materials shall be the components from which the viral vector is obtained, i.e. the master virus vector seed or the plasmids used to transfect the packaging cells and the master cell bank of the packaging cell line.
Last Update: 2014-11-21
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