Precision medicine represents a significant shift in healthcare, moving from a generalized approach to a more personalized strategy that considers a person's genetic makeup, environmental and lifestyle. Within this field, cell and gene therapies have emerged as promising tools for improving patient care—with cell therapy involving the transferring of live cells into a patient and gene therapy modifying a person’s genetic code to treat or cure specific health conditions.
Bioanalysis is crucial for cell and gene therapy development in both the preclinical and clinical phases of drug development. However, given the nature of cell and gene therapies, traditional bioanalytical methodologies and instrumentation originally designed for small and large molecule treatments do not suffice. Specific molecular bioanalytical methodologies and instrumentation for biodistribution, vector shedding, vector copy number, and cellular kinetics are required to advance cell and gene therapies along the drug development continuum.