Navigating the challenges of developing delivery devices for cell and gene therapy products in Europe

The ever-increasing diversity, complexity, and potential therapeutic utility of cell and gene therapies (advanced therapy medicinal products [ATMPs]) is creating new challenges and opportunities in the field of drug delivery, whereby the ATMPs are targeting anatomical locations that may not lend themselves to systemic routes of administration. The rationale for more targeted delivery includes the potential for achieving both enhanced efficacy and safety (fewer/lower doses) for the ultimate benefit of patients. In turn, this could have a positive impact on the commercialization of ATMPs, given the relatively high cost of development, manufacture, and subsequent pricing of the products that have been approved thus far. This article aims to describe some of the challenges associated with the development of medical devices for the delivery of ATMPs, with particular emphasis on the evolving regulatory landscape in the EU and the technical challenges of delivering of ATMPs to challenging anatomical locations, such as the central nervous system (CNS).

Please enter your email to access content Read now