Jeff Heiser
Seminars
Thursday 2nd January 2025
Implementation of Phase Appropriate mRNA Analytics in a Contract Testing Environment: Balancing the Development & Qualification Approach in a mRNA Program
11:45 am
- The analytical requirements for characterization of mRNA Drug Substance and Drug Products have been defined by the USP as well as sponsor companies participating in early phase clinical trials
- Balancing the effort spent on method development and qualification/validation is critical to keeping with timelines and controlling analytical costs
- How to utilize a suite of mRNA Analytical platform methods to streamline your process development team’s ability to optimize the scale up and manufacturing process
- Effective implementation of full cGMP versus process development service analytical offerings in the same lab space
