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.

A person properly dressed in the Ex Vivo facility

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.

A person wearing a white shirt — 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.