This is a facility at Karolinska Institute for safe translation of ATMPs from the research laboratory to the clinic. Pre-GMP means process development done from the research laboratory to production in a GMP facility.
At the pre-GMP facility you can:
– Learn the basics of GMP production
– Transform research protocols into standardized operational procedures (SOPs) under GMP-like conditions
-Develop SOPs and procedures that can be transferred to a GMP facility
– Do validation runs that do not require GMP standards
– This is also a resource for academia, health care and industry
Open for external users?
Yes. There is a different price for external users compared to academic researchers.
User fee?
Yes. There is a fee for the rent of the clean room and additional fees for other services (training, scientific support e.i.)
Education mandatory before access to equipment?
Yes. We have an application form for access to the Pre-GMP facility. Scroll down to “documents”.
How can I book the equipment until the new online booking system will be available?
The facility manager is the entry point for all the projects. Under “Documents” on this page you can find an application form for access to the Pre-GMP facility.
Read more here for how to book and fees.