Implementation of Phase Appropriate mRNA Analytics in a Contract Testing Environment: Balancing the Development & Qualification Approaching a mRNA Program

Time: 1:00 pm
day: Conference Day One


  • 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