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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.
There are six 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
Runar Oddvarson Hårklau, Head of Quality Control (QC)
Anna Boniecka, cleanroom operator
Barbara Van Der Hoven, cleanroom operator
Oline Øie Hovland, cleanroom operator and pre-GMP operator
The GMP personnel. From left: Oline Øie Hovland, Anna Boniecka, Barbara Van Der Hoven, Runar Oddvarson Hårklau, Kimberley Joanne Hatfield and Petra Vogelsang.
Photo: Elise Aasebø
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).
Photos from the Ex vivo facility at Haukeland University Hospital.
Image 1/8
All cell products are studied carefully in the microscope. Photo: Øystein Fykse / Helse Bergen
All cell preparations are performed in a LAF bench, which qualifies to a grade A cleanroom. The laminar air flow inside the bench helps keeping all particles out of the working area.
A cleanroom "suit" is required when entering the facility. The suit is usually static-free, and its purpose is to eliminate all dust and particulate debris from contaminating the clean room. Photo: Øystein Fykse, Helse Bergen
The employees in Ex vivo facility. Talking and large movements should be avoided in the laboratory, as disturbances in the air potentially increase the chances of particles moving to the top of your work surface. Photo: Øystein Fykse, Helse Bergen
One should always walk slowly and carefully through the cleanroom. As you move through the facility, your body will likely create air currents. Photo: Øystein Fykse, Helse Bergen
The areas are routinely controlled for environmental contaminants. We are using contact plates for environmental monitoring of surfaces and personnel in the cleanrooms. Photo: Øystein Fykse, Helse Bergen
Each step of the manufacturing process is monitored and saved for later. Photo: Øystein Fykse, Helse Bergen
Some of the cell products are stored in liquid nitrogen (cryopreservation) in our storage area before further use. Photo: Øystein Fykse, Helse Bergen
Photos from the Ex vivo facility at Haukeland University Hospital.
Image 1/8
Fullscreen images
All cell products are studied carefully in the microscope. Photo: Øystein Fykse / Helse Bergen
All cell preparations are performed in a LAF bench, which qualifies to a grade A cleanroom. The laminar air flow inside the bench helps keeping all particles out of the working area.
A cleanroom "suit" is required when entering the facility. The suit is usually static-free, and its purpose is to eliminate all dust and particulate debris from contaminating the clean room. Photo: Øystein Fykse, Helse Bergen
The employees in Ex vivo facility. Talking and large movements should be avoided in the laboratory, as disturbances in the air potentially increase the chances of particles moving to the top of your work surface. Photo: Øystein Fykse, Helse Bergen
One should always walk slowly and carefully through the cleanroom. As you move through the facility, your body will likely create air currents. Photo: Øystein Fykse, Helse Bergen
The areas are routinely controlled for environmental contaminants. We are using contact plates for environmental monitoring of surfaces and personnel in the cleanrooms. Photo: Øystein Fykse, Helse Bergen
Each step of the manufacturing process is monitored and saved for later. Photo: Øystein Fykse, Helse Bergen
Some of the cell products are stored in liquid nitrogen (cryopreservation) in our storage area before further use. Photo: Øystein Fykse, Helse Bergen
