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Formulation and Delivery
Chalk Talk

Method Transfer and Validation: Lessons Learned and Recommendations for Success

Tuesday, October 22, 2024
9:30 AM – 10:15 AM MT
Location:Spotlight Stage C, Aisle 2800, Exhibit Hall

Sponsored By 

    Chalk Talk Presenter(s)

  • Lynn Kamen, Ph.D.

    Scientific Officer and Executive Director
    BioAgilytix
    Durham, North Carolina

It is widely known that drug development can be an extremely lengthy and time-consuming process that spans decades of work. Throughout the drug development process bioanalytical assays can be transferred throughout the lifecycle of the drug within multiple lab locations and between platform manufacturers. In this presentation, we will highlight the challenges associated with bioanalytical method transfers as well as highlight case studies and strategies for overcoming challenges encountered during method transfer.

Learning Objectives:

  • Upon completion, participants will have an appreciation for the challenges associated with assay transfers and validations.
  • Upon completion, participants will have been shown multiple cases studies that demonstrate considerations for bioanalytical assay transfers.
  • Upon completion, participants will understand important strategies to ensure success when transferring bioanalytical assays.