The Center for Advanced Cell and Gene Therapy (ACT) at OUH, one of the nodes in ATMP Norway, offers support for all steps required to take a research idea to patient treatment. This includes regulatory support, access to laboratories for process development and manufacturing. Customers get access to trained personnel and state-of-the-art equipment to guide them through this critical bottleneck in translating novel concepts to the clinic, describes OCC.

In Oslo, there is a process development facility, also known as a pre-GMP facility, which is essential to deliver cell therapies to patients. ATMP Norway will support the establishment of a similar laboratory at HUH.

“We have a strong infrastructure, but it’s not yet complete. Through our analysis of how to improve ATMP manufacturing efficiency in Norway, we identified one critical missing link in the manufacturing chain: a dedicated, GMP-certified quality control facility,” states Anna Pasetto, Director of the ACT center at OUH, to OCC.

A national quality control laboratory

The funds from the Norwegian Research Council will be used primarily to build a national quality control laboratory, with rooms and equipment that can handle samples from all of Norway, including systems for storage, quarantine and tracking, describes OCC.

“We will also explore how to increase manufacturing capacity through adjusting laboratories for implementation of more automated processes. This is a very exciting development in the field with emergence of robotized systems that seamlessly connect devices through the manufacturing process,” states Pasetto to OCC.

Expansion of Oslo Cancer Cluster

Oslo Cancer Cluster is also expanding with The John Ugelstad Building on the existing Innovation Park next door to the Radium Hospital, with the largest functioning GMP facility in Norway.

Thermo Fisher Scientific, one provider of technical solutions for ATMP, will also move into the new building section with four floors of labs and offices. The global biotech company has strong Norwegian roots since their acquisition of the Norwegian company Dynal and its product Dynabeads, which are used in CAR T cell therapies spearheading the clinical implementation of ATMPs.

“With the presence of Thermo Fisher and other companies in the Incubator, we foster a highly beneficial environment where all the scientists are exceptional, deeply motivated, and fully understand the urgency of our work,” says Pasetto to OCC.

A boost for Norway

With countless support letters from entities in Norway and abroad, ATMP Norway is well-situated to spearhead the development of cell therapies for Norwegian research, healthcare and industry.

“We are becoming more self-sufficient and efficient as we integrate the production chain with a dedicated quality control lab. This transformation makes us increasingly attractive to academics, but also to national and international companies seeking to bring their products to patients,” Karl-Johan Malmberg, a co-applicant of the ATMP Norway grant, fills in.