A need for a novel regulatory framework for individualized neoantigen-specific therapies

Manufacturing of individualized neoantigen-specific therapies for patients takes place one batch at a time. The existing regulatory mechanisms for post-approval changes for traditional products can be applied for limited types of changes to either controls or manufacturing processes for some individualized Advanced Therapy Medicinal Products. However, these existing mechanisms become untenable given the rapid pace of evolution among these therapies and constant innovations in manufacturing technologies (such as next-generation sequencing and bioinformatics workflows). There is a need for a novel regulatory framework for these therapies and mechanisms of pre- and post-approval lifecycle management (such as a predetermined change control plan) that allow for streamlined process updates, to ensure that patients receive products manufactured using the best technologies and most accurate data based on a continuous improvement mindset. The application of relevant medical device regulatory mechanisms to individualized neoantigen-specific therapies is proposed here, as devices have mechanisms for iterative improvements managed in a risk-based approach. While there are ongoing attempts at harmonization of regulatory expectations for lifecycle management, new regulatory mechanisms (and leveraging existing frameworks where available) are needed to avoid some existing pitfalls. A novel regulatory framework is proposed to consider the genomics and bioinformatics workflows as integral parts of the design and end-to-end manufacture of individualized neoantigen-specific immunotherapies.

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