Pre-GMP facility

Pre-GMP development of ATMPs and other gene-based strategies

The project aim to provide the infrastructure, equipment and education needed to develop new ATMPs more efficiently, including support academic research groups and SME at the early phase of their journey to clinical testing.

Time period: 06/2021 – 05/2024

Lead: Matti Sällberg, Karolinska Institutet

Involved partners: KI, KCC/Vecura, Lund University, Umeå University, Region Västerbotten, Uppsala University, Key2compliance

  1. Subproject – Development of HQ plasmid production (continuation)
  2. Subproject – Development of genetically modified T cells
    • The process to manufacture genetically modified T cells expressing HCV-TCR has been set up at the pre-GMP facility using the closed and automated system CliniMACS prodigy from Miltenyi. The experience and SOPs development in the pre-GMP will be used to support projects from Uppsala University and University of Oslo that want to use the Miltenyi Prodigy to manufacture their TCR and CAR-T cells.
    • Time period: 06/2021 – 05/2023
    • Lead: Anna Pasetto, Daniela Nascimento Silva, Karolinska Institutet
    • Involved partners: KCC/Vecura, Cytiva
  3. Subproject – GMP education and training courses focused on ATMPs
    • The overall goal of the project is to develop and implement a comprehensive GMP educational/training program with a specific focus on ATMPs.
    • Time period: 06/2021 – 05/2024
    • Lead: Anna Pasetto, Karolinska Institutet
    • Involved partners: KCC/Vecura, Lund University, Umeå University, Region Västerbotten, Uppsala University, Key2compliance
  4. Subproject – Development of small-medium scale viral vector production
    • Development of SOPs for lenti- and retro- viral vectors production with initial focus on vectors encoding T cell receptors (TCRs) (targeting viral and cancer antigens).
    • Time period: 06/2021 – 05/2024
    • Lead: Michael Chrobok, Karolinska Institutet
    • Involved partners: KCC/Vecura, Cytiva
  5. Subproject – Multi-use RNA production platform for ATMPs, and other gene-based interventions
    • To establish SOPs for production by in vitro transcription, purification and formulation of RNA, that can be transferred to Vecura (or any other similar facility) for GMP production.
    • Time period: 06/2021 – 05/2024
    • Lead: Gustaf Ahlén, Jingyi Yan, Karolinska Institutet
    • Involved partners: KCC/Vecura, SVF

Publications

”Identification and Clinical Application of Immunological Receptors Targeting Mutated Antigens Expressed by Solid Tumors.” https://pubmed.ncbi.nlm.nih.gov/33007884/

”Chronic Viral Liver Diseases: Approaching the Liver Using T Cell Receptor-Mediated Gene Technologies.” https://pubmed.ncbi.nlm.nih.gov/32560123/

Facility aims

The Pre-GMP facility was created within a Centre for Advanced Medical Products (CAMP) project to support researchers and biotech industries (e.g. academia, clinic and SMEs) to successfully overcome road blocks in the process of developing ATMPs.

The first aim of the project has been to build the facility according to the requirements necessary to meet the “clean room” criteria. This is particularly important because it ensures that we can work in the facility with conditions close to real GMP-classified environment.

The pre-GMP facility is mainly focused on projects involving the development of new gene delivery tools/vectors and genetic modification of cells. In the facility it will be possible to develop new products and protocols, test new devices for production, purification and analysis.