Projects in the Pre-GMP facility
Discover projects developed in the Pre-GMP facility, where expert support turns early research into optimised manufacturing processes for clinical translation.
Elicera
Together with the team at pre-GMP, Elicera developed and optimised the manufacturing process for CAR20(NAP)-T (ELC-301), moving it from laboratory-scale protocol to a clinical-grade process suitable for GMP transfer. The work covered CliniMACS Prodigy process adaption and qualification, analytical method development, and established the inter-process control parameters and release testing strategies that now underpins their IMPD development and more importantly the clinical trial application to initiate the FiH CARMA-01 trial. Read more about Elicera.
"The Pre-GMP facility was an essential bridge between our academic research and clinical translation. The expertise and hands-on support from Pre-GMP and Vecura allowed us to take a laboratory process and turn it into something robust enough for GMP manufacturing — a step that would have been very difficult to take on our own."
-Di Yu, Associate Professor of Immunotherapy, Uppsala University
Pasetto project
At the Pre-GMP facility at Karolinska Institutet, the Pasetto project are optimizing ex vivo genetic engineering strategies for T cells using viral, non-viral, and combined approaches. The goal is to enhance the functionality and resilience of TCR- and CAR-engineered T cells in solid tumors while developing robust, reproducible, and clinically compatible protocols suitable for translation into cell therapy trials, with ongoing work in hepatocellular carcinoma (HCC) and diffuse intrinsic pontine glioma (DIPG). This work is carried out in close collaboration with the pre-GMP facility at the Radiumhospitalet, Oslo University Hospital, facilitating alignment between research development and clinical translation at both sites.
VIVAC lab
The VIVAC research group focuses on the development of vaccines and novel immunotherapies against viral diseases and cancer, using genetic vaccine platforms based on DNA and mRNA-LNP technologies. Its mRNA-LNP vaccines have been developed and characterised at the Pre-GMP Facility.
"Having access to the Pre-GMP mRNA-LNP platform has been highly valuable for our vaccine development programmes. It allows us to move efficiently from vaccine design and early research towards reproducible mRNA-LNP production and preclinical testing, while establishing processes that can ultimately support GMP manufacturing. We have mRNA vaccine programs related to emerging infections and pandemic preparedness such as CCHF, Ebola, and Hantaviruses that now can move very fast."
-Matti Sällberg, Professor, Karolinska Institutet
Additional projects
Selected projects in Pre-GMP during 2020-2026
- COVID-19 and HIV-1 antiviral drug development - CRISPR based antivirals.
- Isolation of TCRs specific for shared hotspot mutations from peripheral blood lymphocytes; and development of closed Sleeping Beauty transposition manufacturing process.
- Development of small-medium scale Lenti viral vector production.
- Process Development for Adoptive Cell Therapy. Clinical-Scale Manufacturing of Multiple TCR-T Cell Products.
- Establishment of a reproducible process for HQ plasmid production.
- Process development and validation of a closed‑system manufacturing workflow for CAR‑T cells targeting B‑cell lymphoma.
- Implementation of GLP-standard assays for immunogenicity testing.
- Development and validation of a potency assay to support a Phase I clinical trial drug product.
- mRNA-LNP platform producing reporter and custom mRNA, as well as lipid formulations.