Jeff Heiser

Chief Scientific Officer, Microbial & Advanced Therapeutic Platforms BA Sciences

Seminars

Wednesday 23rd July 2025
Implementation of Phase Appropriate mRNA Analytics in a Contract Testing Environment: Balancing the Development & Qualification Approach in a mRNA Program
11:15 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

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