A structured approach to addressing leachable risk in cell and gene therapies

The purpose of this article is to demonstrate the importance of a structured approach to the determination of leachable risk within a given cell or gene-based therapy (CGT). These drug product types offer a unique challenge in that it is impractical to make leachable measurement directly in the final drug product. A ‘simulation’ of leachable present needs to be made. The suitability of that simulation is dependent on knowledge and understanding, and this article will offer an opinion on how this is best achieved through a structured process beginning with process mapping and the development of a risk assessment process. In this process, leachable risk is identified, scored, evaluated. Then experiments are designed to map the risk to achieve risk mitigation via mechanism which include simulated leachable studies. Using such an approach not only is the leachable risk addressed but it provides a mechanism to better ensure the testing done best represents accurately the true risk of leachables in CGT.