mRNA Quality Assessment and USP Guidelines

Following the rapid and successful deployment of mRNA vaccines during the COVID-19 pandemic, over 150 mRNA vaccines are in development, with further therapeutic applications in oncology, cardiovascular and genetic diseases and forecasts predict a high level of growth in products using this drug manufacturing platform. USP engaged with stakeholders in government, drug development, pharmaceutical companies and other experts to build consensus on relevant quality attributes for mRNA-based products and appropriate analytical methods. As part of this effort, USP worked with vaccine experts to generate draft guidelines (Analytical Procedures for mRNA Vaccine Quality) and solicited feedback from stakeholders to update and evolve the guidelines. This presentation will provide an overview of USP updated guidelines and plans for further assessment and qualification of analytical methods presented therein. Physical, chemical, and structural elements of drug substance and drug product and how they relate to product quality attributes will also be discussed.

Presented by John F. Cipollo, Ph.D. Team Lead and Senior Principal Scientist, Global Biologics at US Pharmacopeia

Prior to joining USP Dr. Cipollo founded and led the Vaccine Structure Group at US FDA CBER. His group focused on vaccine antigen structure, pathogen interaction with the host immune system, and development of mass spectrometry based and other analytical methods as well as supporting informatics.  He served as a CMC reviewer for a wide range of vaccines for over 15 years. John’s role at USP includes leveraging his experience in vaccine research and review to lead efforts towards identifying and advancing the development of documentary and physical standards to support vaccine development and manufacture. His efforts also include educational outreach to foster greater understanding of the principles of vaccine development, production, and quality as well as their importance in human health.

Followed by Khaled Yamout, Senior Director, Analytical Services and Quality Control at TriLink Biotechnologies.

Khaled Yamout is the Senior Director, Analytical Services and Quality Control at TriLink Biotechnologies where he oversees 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 a number of 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.

Sponsored by TriLink Technologies

TriLink BioTechnologies, a Maravai LifeSciences company, is helping to realize the power and potential of mRNA. As a global leader in nucleic acid and mRNA solutions for more than 25 years, TriLink delivers unrivaled chemical and biological experience, CDMO services, and high-quality readymade and custom materials, including its proprietary CleanCap® mRNA capping technology. Pharmaceutical leaders, biotech disruptors and world governments depend on TriLink to meet their greatest challenges, from delivering the COVID-19 vaccine at warp speed, to empowering innovative treatments in oncology, infectious diseases, cardiology, and neurological disorders, to enabling future pandemic response plans