As with other drug molecules, ATMP’s have to comply to the Good Manufacturing Practice (GMP) guidelines, which require the meticulous assessment of both quality and consistency of the end product. This needs a careful monitoring of the entire manufacturing process, which is both a challenge and an opportunity for the ATMP field. Investing in efficient, innovative, reliable, automated, digitally monitored processes, will position ATMP as a frontrunner within the pharmaceutical sector, attracting additional funding and making way for improvements in other product areas. Yet, contrary to what one might expect, developers today are often not embracing automation or even digital transformation. A quick survey of developers indicates 3 main hurdles with regard to digitalized monitoring and record keeping. In this article, we take a closer look.
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