mRNA Products: An Overview on Strategy for Potency for DS vs DP

The development of mRNA-based medicines requires robust potency assays to assess both translatability and biological activity. These assays can be either cell-free or cell-based assays; each provide a different assessment but are complementary to each other. As such, we will discuss various strategies for assessing mRNA DS and DP potency evaluation and the advantages and disadvantages between cell-free and cell-based assays.

Presented by Khaled Yamout, Analytical Sciences, Quality and Manufacturing Consultant, Yamout Chem Consulting, LLC

Khaled Yamout is a thought leader in Analytical Sciences, Quality and Manufacturing.  Previously held a position as a Senior Director, Analytical Services and Quality Control at TriLink Biotechnologies where he oversaw the Analytical Sciences Center of Excellence and all analytical aspects of method development and validation to product release and stability to support regulatory filings for both small and large molecules. Prior to TriLink, Khaled held various positions in Quality Control, Research and Development, and Manufacturing where he supported several Drug substances and Drug products (both small molecules and biologics) from clinical phase to commercial. These include diverse experience and expertise ranging from discovery to manufacturing with Fortune 500 firms, as well as small entrepreneurial businesses in the areas of synthetic, analytical, colloidal, surface modification, protein, and antibody modification and purification covering both manufacturing and analytical testing and characterization.

Followed by a live Question and Answer session