Lexology January 9, 2025
Advances in precision medicine (also known as “personalized medicine”) have led to an improved understanding of mechanisms underlying disease and the emergence of new tools and technologies, such as next generation sequencing technologies. Novel diagnostics and individualized therapeutics for diagnosis and treatment tailored to specific characteristics can now target disease based on an individual’s genetic makeup. Cell and gene therapies in particular, such as adeno-associated virus vectors and Chimeric Antigen Receptor T-Cell products (“CAR-T cell therapies”), hold great potential in battling rare diseases that present in small patient populations.
The complexity of the manufacturing processes that underpin these therapies, however, presents obstacles to their commercial uptake and success. For example, personalized medicines are generally biologically complex and have a short...
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