The requirements for the quality control (QC) of biological medicinal products are defined in guidance documents produced by regulatory agencies and international organizations such as EMA, US FDA, Japanese PMDA, ICH and WHO. Although these guidance documents are revised periodically, these revisions usually lag behind scientific advances and technical innovations.
This webinar describes a number of topics in the areas of cell line characterization and bulk harvest testing for contaminants where new technical innovations are occurring. The regulatory response to these developments are discussed.
Topics that will be covered include: