In contrast to mammalian cell systems, the plant cell-based PCP technology enables the rapid and flexible production of complex biopharmaceuticals, but so far has been limited by process engineering and regulatory transfer barriers. Using a co-creation approach, an open experimental space—a PCP demonstrator—is to be developed, allowing companies to test the GMP-compliant production of their candidates and qualify the PCP technology for their specific applications.
The main steps include the establishment of the demonstrator at Fraunhofer IME and the specification of GMP-compatible equipment and processes. For the latter, three workshops—at the beginning, midpoint, and end of the project—will be held to jointly develop a GMP concept in collaboration with regulatory authorities and interested companies.
The completed demonstrator, serving as an experimental platform for simple and rapid product testing, will then be validated using three representative product candidates (FGF21, TGF1β, and ferritin). In this context, the possibility of product-specific adjustments will also be tested together with participating companies. The results will be shared with all stakeholders and made publicly accessible through open-access publications.
By establishing this experimental demonstrator, the entry barriers for the PCP technology can be overcome through co-creation, enabling its broader adoption and helping to close the gap in the production of complex biopharmaceuticals at medium-scale capacities. The wider dissemination and simplified implementation of the technology will promote new developments and business models, thereby strengthening Germany’s position as an innovation hub.
Fraunhofer Institute for Molecular Biology and Applied Ecology IME
