Course Description:
The development and approval of mRNA-based vaccines for COVID-19 revealed the potential of this platform for both preventative and therapeutic purposes and has led to an explosion of mRNA-based products in development. Compared to traditional biotherapeutics, mRNA products have advantages in terms of flexibility and speed, but also introduce a new paradigm for testing due to the use of novel raw materials and delivery systems as well as unique product quality attributes and impurities. The cell-free manufacturing process utilizes several raw materials, such as capping reagents, nucleosides, enzymes, plasmid, and LNP components, for which quality and consistency need to be assessed and ensured. One of the advantages of the mRNA modality is that mRNA-based products share common physiochemical properties, making them amenable to platform analytical methods.
Given the rapid development of mRNA vaccines, there are several challenges that needs to be addressed from the regulatory perspective. To assure safety and quality of mRNA vaccines, comprehensive chemistry, manufacturing, and control (CMC) information is required. In addition, control strategies of the starting raw materials and manufacturing process, as well as a comprehensive characterization and release testing of drug substance and drug product is also expected from the regulators.
The webinar will focus on:
- Focus on analytical approaches that support quality of mRNA-based products
- Identify critical raw materials for mRNA products and their quality attributes
- Propose platform methods and testing strategies that can be used to assess mRNA quality
- Overview of some of the technical requirements for CMC
- Highlight some of the control strategies of the manufacturing process and final drug product
Who should participate:
Suppliers and manufacturers of mRNA vaccine drug substances, contract manufacturing organizations, drug testing organizations, regulatory agencies, and QA/QC specialists.
Since the platform is amenable to other biologics outside of the vaccine space, such as cancer and enzyme replacement therapies, those interested in these biologics are also encouraged to attend.
The live version of this recording took place on January 18, 2024.
Access Duration:
Access to this course expires 60 days from the date of registration or until you mark the course ‘Complete’ – whichever occurs first.
Speaker:
Sarita Acharya<