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.
BioPhorum Advanced Therapy Medicinal Products wanted to consolidate opinions and make recommendations to promote alignment in this area and has published slides on Industry recommendations for phase appropriate approach for assay validation in Cell and Gene Therapies (CGTs).
With the increased number of approved CGT products on the market, authorities are developing more guidance regarding regulatory requirements. The phase-appropriate approach to assay validation should always use the most up-to-date regulatory guidance. 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.
The result of having insufficient and/or inadequate data packages leads to an increased risk of delays in regulatory filing and approval of the clinical candidates. Given the often-accelerated pace of CGT clinical programs of therapies targeted for patients with unmet medical needs, or where other traditional treatments may have been insufficient, any delays to the regulatory approval process could have a significant impact on the availability of drugs to patients. If you have experienced any of these problems, this paper is for you.