Implementation of Phase Appropriate mRNA Analytics in a Contract Testing Environment: Balancing the Development & Qualification Approach in a mRNA Program
- 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 trialsÂ
- Balancing the effort spent on method development and qualification/validation is critical to keeping with timelines and controlling analytical costsÂ
- 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 processÂ
- Effective implementation of full cGMP versus process development service analytical offerings in the same lab space