The pre-GMP laboratory at Karolinska Institutet gives companies the opportunity to develop products, drugs and treatments. It is hoped for an increased interest from the industry to cooperate. Professor Matti Sällberg, head of the pre GMP unit, talks more about how this can be helpful early in the development.

Matti Sällberg, professor of biomedical analysis at KI in Flemingsberg. Photo: Erik Flyg.

What is pre-GMP?
– A pre-GMP facility facilitates the transition from having made a discovery in the research lab to it being developed for drug production, ie according to Good Manufacturing Practice (GMP). In the pre-GMP facility you can test techniques and develop protocols which are then transferred to a GMP unit. In this way, development becomes easier and cheaper.

How long have you been around?
– We have been around for about 3 years.

How unique are you?
– We are currently the only pre-GMP unit, but there are more under construction or at the planning stage. A similar facility is Testa Center in Uppsala.

Can you tell us about an exciting project?
– A project that has just started, and which recently received funding via Vinnova, is called LaScarna. There are three issues:

• to set up production of mRNA for research at the pre-GMP unit
• for treatment within phase 1 studies at Vecura at Karolinska University Hospital
• for large-scale production at Northx Biologics in Matfors.

We hope here that we will create a good chain so that researchers who develop mRNA-based drugs can have access to materials for research as well as large clinical studies and ultimately pure drug production.

Can you as a company turn to you for help?
– All the help you need. Everything from advice to help with the manufacture of various cells or gene-based products.

What is good to think about before contacting you?
– It is possible to contact us for all types of questions, we do our best to help and ensure that the companies get it right.

What type of project is coming to you?
– Usually projects where you see that there is potential to develop into a product or a drug / treatment.
Stockholm Life Tech is a project funded by the European Structural Funds. You are part of the project, what do you hope to get out of it?
– We see it as a way to improve the marketing of the pre-GMP laboratory and to increase the interest from the industry to collaborate with academic and clinical researchers to develop new treatments that will ultimately benefit patients.