The development of advanced therapy medicinal products (ATMPs) is progressing rapidly. ATMPs are tissue-engineered products as well as cell and gene therapies. The first products are already on the market and new therapies are being approved all the time. ATMPs are either manufactured for a specific patient or only in small batches, resulting in complex manual processes and high production costs. The full clinical potential can therefore not be realized unless next-generation manufacturing technologies are developed.
To increase the availability of ATMPs for patients and to lower costs, new concepts are needed along the entire value chain. This could be achieved by increasing the level of automation and digitalization in the production of cell and gene therapies.
The Fraunhofer Institute for Manufacturing Engineering and Automation IPA, based in Stuttgart, is an internationally recognized research institution for innovative work in the field of manufacturing technologies. With 25 years of experience and expertise in laboratory automation and production processes, IPA has the know-how to realize the vision of personalized production. IPA’s interdisciplinary team focuses on the fields of biology and the development of software & hardware to deliver comprehensive solutions.
This provides a sound basis for research into automating cell and gene therapies, both of which are unique and highly personalized areas of science. Overall, the Institute is well positioned to explore this new field and, at the same time, to improve industry standards governing mass personalization and sustainability.
In cooperation with other research institutes, universities and industry, Fraunhofer IPA has been conducting R&D work on this topic in a variety of publicly-funded projects for many years.