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Hybrid LC–MS Assays Reaching Standards for Regulatory Filing

The growing interest in biotherapeutic drug analysis is increasingly requiring high-sensitivity assays for PK determination. Particularly, hybrid LC–MS/MS methods have been regarded as the best and possibly the only, valid alternative to traditional immunoassays.

This presentation will describe standard hybrid LC–MS/MS bioanalytical workflows for the determination of therapeutic antibodies in clinical and preclinical samples and validation of these methods for non-clinical and clinical PK evaluation, in accordance to the current guidelines. Specific emphasis will be given to the optimization of sample preparation aimed at producing robust and compliant methods across different matrices and species.

What will you learn?

  • How to define the optimal bioanalytical approach?
  • How to apply LC–MS/MS method for the bioanalysis of biotherapeutics?
  • How to address critical steps in sample preparation?



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