The Ex vivo facility (EVF) is a cell production laboratory situated on floor 1M of the Laboratory building at Haukeland University Hospital.
The facility features four manufacturing rooms, with cleanroom grade B, C and D (ISO-5, -7 and -8). There is also a quality control testing lab and a storage area for cryopreservation of products.
The facility will manufacture products, so-called advanced therapy medicinal products (ATMPs), for clinical investigators, and also manufacture high-quality products for other academic and industry partners.
There are three highly educated employees whom are currently being qualified for working in the EVF; the head of Quality assurance (QA) and qualified person (QP) Kimberley Joanne Hatfield, Head of Production Petra Vogelsang, and Head of Quality Control (QC) Elin Strand.
The facility takes care of maintaining and service of instruments and qualification of the necessary infrastructure for manufacturing purposes. Our primary goal in 2022 is to work toward obtaining a GMP certificate and manufacturing authorization. To manufacture medicinal products, a potential authorization holder must demonstrate compliance with the principles of Good manufacturing practice (GMP), and a manufacturing authorization must be obtained from the Norwegian Medicines Agency.
The three employees at the Ex vivo facility – the team who will manufacture cell products for the clinical trials associated with the Mohn Research Centre for Regenerative Medicine – recently received training at the cell manufacturing centre in Ulm, Germany. Under the close supervision of Dr. Markus Rojewski and colleagues, they learned how to manufacture mesenchymal stromal cells (MSCs) according to Good Manufacturing Practice (GMP).