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Our cell production laboratory
GMP Infrastructure
The Ex-vivo facility (EVF) is a cell production laboratory situated on floor 1M of the Laboratory building at Haukeland University Hospital.
Photo: Øystein Fykse / Helse Bergen
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.
Anna Boniecka. Photo: Petra Vogelsang
There are four highly educated employees whom are currently being qualified for working in the EVF:
Kimberley Joanne Hatfield, the head of Quality assurance (QA) and qualified person (QP)
Petra Vogelsang, Head of Production
Elin Strand, Head of Quality Control (QC)
Anna Boniecka, cleanroom operator
From left to right: Elin Strand, Kimberley Joanne Hatfield and Petra Vogelsang. Photo: Øystein Fykse / Helse Bergen
The facility takes care of maintaining and service of instruments and qualification of the necessary infrastructure for manufacturing purposes. Our primary goal is to work towards 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.
Kimberley Joanne Hatfield
Head of Section for Cell-based Medicinal Products (CMP), head of Quality assurance (QA) and qualified person (QP)
If you are planning for GMP manufacturing of cellular products, please contact Head of Section for Cell-based Medicinal Products (CMP).
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GMP training in Ulm!
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).
