ISPE Glossary of Pharmaceutical and Biotechnology Terminology

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Final Bulk Vaccine

Material that has undergone all the steps of production except for the final filling. It consists of one or monovalent pooled harvests, from cultures of one or more species or types of microorganism, after clarification, dilution or addition of ant adjuvant or other auxiliary substance. It is treated to ensure its homogeneity and is used for filling the containers of one or more final lots (batches).

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