Chemically Modified mRNA as a Biologic: Developing an Analytical Framework for Success

Register free: https://www.pharmtech.com/pt/framework

Event Overview:
Developing an analytical framework for success using a chemically modified mRNA can be compared with those for traditional biologics. Though much of the regulatory filing requirements can be compared with those for traditional biologics, others are not yet well defined. As such, it’s especially important that control on quality and consistency is maintained to ensure efficacy, purity, and safety.
Like traditional biologic products and processes, mRNA-based products require controls on:

• Quality of the starting material (including cell banking)
• Consistency of manufacturing processes
• Identification of critical process parameters
• Clearance of impurities
• Establishment of environmental controls to meet safety requirements
• Thorough characterization of structure, purity, and efficacy

We will discuss some of these challenges and solutions to support the requirements for characterization of structure, purity, and, efficacy of a well characterized mRNA drug substance

Key Learning Objectives:

• Critical raw materials to support the synthesis of mRNA for therapeutic development
• Drawing quality parallels between biological molecules and mRNA
• Characterization of structure, purity, and efficacy of an mRNA drug substance

Who Should Attend:

• Process development scientists in pharmaceutical companies
• QC/QA analysts
• CMC and regulatory affairs personnel
• Program department heads and pharmaceutical executives

Khaled Yamout
Senior Director, Manufacturing and Quality Control
TriLink BioTechnologies

Khaled Yamout is the Senior Director of Manufacturing 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

Register free: https://www.pharmtech.com/pt/framework