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