Current Regulatory Expectations And Technical Advances In The Quality Control Of Biological Medicinal Products

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:

• Current and new approaches to genetic stability and clonality determinations
• New approaches to cell line identity testing
• Spiroplasma testing
• Evaluation of in vitro and in vivo assays for extraneous agent detection and replacement of in vivo assays
• Recommendations for the virus evaluation of Investigational Medicinal Products (IMPs) from EMA and US FDA