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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.

En person kledd i renromsbekledning i Ex-vivo fasiliteten

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.​
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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. 
 
En person iført en hvit skjorte
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  
Three female employees in uniform. Photo
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. 
 
Et nærbilde av en person som smiler

Kimberley Joanne Hatfield

Head of Section for Cell-based Medicinal Products (CMP), head of Quality assurance (QA) and qualified person (QP)

kimberley.joanne.hatfield@helse-bergen.no

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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Employees in Ex vivo facility, looking in microscope. Photo
Employees in Ex vivo facility.
Employees in Ex vivo facility
Employees in Ex vivo facility
Employees in Ex vivo facility
Employees in Ex vivo facility
Employees in Ex vivo facility
Employees in Ex vivo facility

Official opening of the Ex Vivo Facility

There was a large turnout when the chairman of Helse Bergen, Terje Breivik, cut the ribbon for the new and advanced laboratory.

"As the chairman of Helse Bergen, it is a great and very gratifying experience to welcome everyone to such an important event, and not least such an important collaborative initiative," said Breivik before officially declaring the laboratory open.

Grand opening of the Ex Vivo Facility (in Norwegian)
En mann og kvinne som holder et rødt bånd

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).
Read more here!
MSC manufacturing in the cleanroom.
Maŋemus ođastuvvon 2024-08-28