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Bioanalytical Track

Case Studies Showcasing LC-MS Considerations for Specialized Therapeutic Areas

Tuesday, July 15, 2025
12:00 PM - 12:30 PM ET
Location: Vienna Ballroom: South, East + West

Sponsored By 
Description: We will be presenting case studies highlighting the challenges of specialized chemical modalities and therapeutic areas using LC-MS. One case study addresses unique considerations when developing a method on LC-MS/MS for a patient population suffering from sickle cell anemia and addressing the co-medication challenges of a test site being located in a malaria-stricken area. The case study focuses on disease state matrix effects, hemolysis in study samples, and the potential for interference of steady-state levels of other drugs that are not strictly part of the clinical protocol. A second case study addresses the challenges of analytical method development of oligonucleotides with a focus on chromatography and response with and without ion pairing reagents.

Learning Objectives:

  • Identify therapeutic area-specific factors beyond regulatory guidance to enhance LC-MS method robustness, particularly in addressing unique disease-state matrix effects that may impact analytical performance.
  • Develop LC-MS methods that fulfill study objectives while proactively identifying and mitigating risks from potential interferants in patient populations, including those not explicitly addressed in study protocols.
  • Streamline oligonucleotide LC-MS method development by eliminating ion-pairing reagents while maintaining sensitivity and chromatographic integrity to ensure reliable and efficient analytical performance.