A phase-appropriate approach to assay validation continues to be a widely accepted and adopted strategy to support the clinical development of general biologics; cell and gene (CGT) therapies are no exception.
However, current regulatory guidance is inadequate for sufficiently guiding and supporting the phase-appropriate readiness of analytical assays used in all phases of CGT clinical development and regulatory filing.
This insufficient clarity has led to a lack of consensus within the cell and gene community for the phase-appropriate development and validation of the analytical assays utilized at all phases of the CGT product lifecycle.
In this presentation, members of BioPhorum Advanced Therapy Medicinal Products present their consolidated opinions and recommendations to promote alignment on a common phase-appropriate approach to analytical assay validation with respect to the critical quality attributes of the most common CGT modalities. The team’s recommendations are aimed at providing a faster and more efficient route to CGT product development that is compliant with the regulatory standards.
The slides cover:
- The product and methods lifecycle, including analytical method bridging (with examples)
- The regulatory landscape – guidelines associated with analytical methods development and validation
- Determining a phase-appropriate approach to assay validation, including recommendations for the scope of method qualification.