Course Description:This webinar will cover general principles and modes of action for mRNA vaccines. It will also cover the production process including intermediates, raw materials, components of the drug substance, and drug product. The relationship of physicochemical aspects of DS and DP to quality attributes will be discussed.
The webinar will focus on:
- mRNA Vaccines and Mode of Action
- Characteristics of the mRNA Drug Substance
- Nucleoside Analogues: Stability by design
- Poly A Tail: Dialing in another component of stability
- mRNA Drug Substance (DS) Manufacture
- Manufacturing Process: Components of Purification
- Troubleshooting the Reaction
- Drug Product Production: mRNA-loaded LNP
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 December 7, 2023
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:
John Cipollo
Senior Principal Scientist, USP Global Biologics