ATMP Sweden ATMP Sweden Current initiatives CAMP CAMP Projects HQ plasmid production

HQ plasmid production

Development of HQ plasmid production

The purpose of the project is to harmonize plasmid production, for use in pre-clinical/ toxicological studies, between the pre-GMP facility at KI and the HQ DNA facility at NorthX Biologics in Matfors.

Time period: 06/2021 – 05/2024

Lead: Gustaf Ahlén, Karolinska Institutet

Involved partners: KCC/Vecura, NorthX Biologics, SVF

The project aims to see if it is possible to harmonize the HQ plamsid production at the pre-GMP laboratory at KI with the production of HQ plasmid at NorthX Biologics. This will allow researchers to develop production of HQ plasmid for virus production and tox studies on a small scale and at the same time ensure that there is a harmonized provider of GMP quality plasmid for clinical trials amd large scale production. Thus, this benefits all parties, the researcher/small company, KI, and NorthX Biologics.

Examples of tasks and actions:

  • Analyze if harmonization is possible from and IP/legal perspective, meet with MPA to get their opinion
  • Analyze equipment and protocols
  • Produce test batch and analyze quality