Karolinska ATMP Center, a collaboration between Karolinska Institutet and Karolinska University Hospital, is now opening a new mRNA infrastructure at the pre-GMP facility on the Flemingsberg campus. This new environment provides researchers and clinicians with the opportunity to produce mRNA and formulate it in lipid nanparticles (LNPs) for research purposes.
The initiative strengthens the capacity for mRNA-based research and is aimed at projects that use mRNA as a tool in areas such as vaccines, immunotherapy, gene therapy, CRISPR technologies, protein replacement, or rare diseases.
"mRNA is a powerful tool because it can be programmed to express virtually any gene. This makes the technology invaluable in the development of tomorrow's advanced therapies," says Matti Sällberg , professor at Karolinska Institutet and chair of the steering committee for the pre-GMP facility, part of Karolinska ATMP Center.
The infrastructure enables researchers to produce mRNA in different formats, either as so-called "naked" mRNA or formulated in lipid nanoparticles (LNP). The workflows are modular, meaning that researchers can select the parts of the process that best match the needs of their project, whether this involves production of a finalised mRNA design or early support in developing the material required to proceed further in the development pipeline.
"In our pre-GMP environment, researchers can either receive support in producing mRNA-LNPs or establish their own production using our platform. We provide a flexible development setting where mRNA is produced and optimised for preclinical studies, creating a strong foundation for projects that may later progress towards GMP manufacturing and clinical trials," says Lara Sweetapple , researcher at Karolinska Institutet and operational lead of the new infrastructure.
The infrastructure offers support, including:
- production of project-specific mRNA for research use
- access to reporter mRNA
- mRNA formulation in LNP
- mRNA design
- method development and process optimisation
The pre-GMP facility acts as a bridge between basic research and future GMP manufacturing. In this environment, methods can be tested and protocols validated before processes are transferred to GMP facilities, such as Vecura at the Karolinska University Hospital, in preparation for clinical studies. The goal is to offer GMP-grade mRNA by 2027.
What are mRNA and LNPs?
mRNA (messenger RNA) is a molecule that acts as the cell's set of instructions. It tells the cell which protein to produce. By supplying mRNA, researchers can control which proteins are generated for a short period of time - for example, to activate the immune system, or replace a missing protein.
LNPs (lipid nanoparticles) are extremely small fat-based particles that protect mRNA and help it enter cells. Without this protective shell, mRNA is rapidly broken down. LNPs act as a delivery vehicle, enabling mRNA to reach the right place in the body and carry out its intended function.
