Sahlgrenska to establish pre-GMP laboratory for ATMP developers
A pre-GMP laboratory in Western Sweden will let ATMP developers prove out their manufacturing processes before committing to a GMP facility. It is one of two resources in Precisionsplattformen, backed by SEK 25 million in EU regional development and Västra Götalandsregionen funding.
A Bridge Between the Bench and GMP
Sahlgrenska Universitetssjukhuset is establishing a pre-GMP laboratory as part of Precisionsplattformen, a new platform funded with SEK 25 million from the European Regional Development Fund and Västra Götalandsregionen. The laboratory will sit between research laboratories and GMP manufacturing, giving researchers and developers somewhere to build, optimise and verify their production processes before those processes move into a GMP environment.
That transfer is where ATMP projects routinely lose time and money. Process work carried out inside a GMP facility takes on the full cost and documentation burden of GMP while producing no clinical material. Moving it upstream should cut development risk, shorten lead times and open cheaper routes from research to clinical application.
Two Resources, One Platform
The pre-GMP laboratory is one of two resources being built under Precisionsplattformen. The other is a Health Data Sandbox, a secure test and computing environment where researchers, companies and clinicians can develop and evaluate AI-based decision support, diagnostic tools and other data-driven solutions. Sahlgrenska Universitetssjukhuset leads the initiative and runs it together with Göteborgs universitet, Chalmers and Sahlgrenska Science Park.
Jenny Nyström, professor and dean at Sahlgrenska akademin, singled out ATMP as an area where the investment matters, describing it as building on an existing regional environment for advanced therapies, health data, AI and precision medicine. The platform is presented as a concrete step in delivering Agenda för västsvensk life science, the regional life science strategy.
Upstream of Capacity the Region Already Has
The laboratory sits on top of infrastructure that is already in place. Sahlgrenska ATMP-centrum serves as a single entry point for companies and academic groups working on cell, gene, tissue-engineered and combined therapies, and it provides access to GMP facilities alongside advisory and clinical trial support. The new laboratory adds the step between the research bench and GMP production.
The wider regional push points the same way. In May, Västra Götalandsregionen and Business Region Göteborg gathered fourteen life science actors behind a joint declaration that named company-initiated clinical trials as a capacity the region intends to build. Manufacturing readiness is part of what that takes.
Researchers and companies interested in the laboratory can approach Sahlgrenska ATMP-centrum, which handles enquiries on ATMP development across the region.
