HQ plasmid production
Harmonizing HQ plasmid production between pre-GMP and GMP sites.
Lead: Karolinska Institutet – Matti Sällberg
Involved partners: Cobra Biologics, Vecura/Karolinska University Hospital, Adlego AB, Svenska Vaccinfabriken Produktion AB
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 Cobra. 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 Cobra
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
Interview with project leader
Hi Matti Sällberg!
What is the need your project addresses?
This project fills a gap where the researcher/small company needs a smaller amount of HQ quality plasmid for tox and/or virus production but are not ready to go to larger commercial vendors that may not be interested in these smaller scales.
What is your approach to meet the need?
The pre-GMP will develop small scale HQ plasmid production using a procedure harmonized with Cobra
How will this improve Sweden´s capabilities within ATMPs?
We hope this will make it simpler and cheaper to test your products in a smaller scale before entering into clinical trials. At the same time the harmonization with Cobra ensures that if the project is successfull there is at leats one commercial producer to which you directly can transfer your plasmid for GMP production
For more information please contact Matti Sellberg