Whole genome sequencing and analysis of live biotherapeutic products
European Pharmaceutical Review
DECEMBER 21, 2022
The US Food and Drug Administration (FDA) created live biotherapeutic products (LBP) as a new category in the 2012 guidelines. 1 The European Directorate for the Quality of Medicines & Healthcare (EDQM) also accepted LBP as a new category of medicinal products for the European market in 2019.
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