Bioanalysis Zone

Flow cytometry in cell-based pharmacokinetics or cellular kinetics in adoptive cell therapy

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Pharmacokinetics (PK) defines the disposition of a drug in the body based primarily on measurements in fluids or tissues by various bioanalytical methods during the drug development. Most bioanalytical methods utilize ligand-binding or LC–MS technology, and the assays are validated and applied following the guidelines from various regulatory agencies in their countries (e.g., US FDA, EMEA or Health Canada) [1]. These bioanalytical method guidelines focus on the PK of traditional drug compounds; small molecules and large biomolecules.

The CAR-T (chimeric antigen receptor) cell therapies, recently approved by FDA, involve administration of ‘living drugs’ capable of

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