NOK 50 million to establish a new ATMP infrastructure

The Research Council of Norway has recently granted NOK 50 million to the Oslo University Hospital (OUH), in partnership with the University of Oslo and the Haukeland University Hospital (HUH) for the development and distribution of ATMPs.

“ATMPs represent a powerful therapeutic modality perhaps best illustrated by the unprecedented clinical success of cancer immunotherapy and chimeric antigen receptor (CAR) T cell therapy for B cell malignancies and autoimmune diseases. A unique feature of ATMPs is the potential for long-term cure, where conventional therapies typically have temporary benefits,” explains Anna Pasetto, Director of the Center for Advanced Cell and Gene Therapy (ACT) at OUH.

Delivering cutting-edge therapies

The ACT centre, 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.

Missing infrastructure

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,” explains Pasetto.

Manufacturing cell therapies require adherence to strict regulations to ensure product quality and safety. Additionally, specific assays must be conducted whenever genetically modified cells are infused into patients.

“At present, these tests are outsourced to commercial providers in other countries, resulting in significant costs, logistical challenges, and delays from shipping samples across Europe. Waiting weeks or even months for results is simply not sustainable,” comments Pasetto.

Quality control facility

Filling this gap, 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.

“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,” Pasetto continues.

Expansion of Oslo Cancer Cluster

As a fortunate circumstance, Oslo Cancer Cluster is 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.

“This allowed us to custom design the new laboratory to meet all the requirements,” says Pasetto.

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.

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.

Decreasing the costs

Cell therapies against cancer have always been associated with a high cost, but Pasetto doesn’t think it has to be like this.

“I think we can find new technologies to produce cell therapies at a lower cost. The regulatory authorities are becoming more experienced in this field, so we can find strategies that allow us to bring the therapy faster to the patient, while still being safe and within compliance. We can shorten the time to manufacture, and at the same time, make a safer and more individualised product,” says Pasetto.