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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)
