Advanced Cell Therapy Unit – ACT Centre

Back row: Thomas Olsen Nesset, Kristina Stokland and Helene Dahle Midttun.
Front row: Anniken Waage Fougner, Anna Pasetto and Julia Zeun.

 
Expertise and services

The Advanced Cell Therapy Unit, known as the ACT Centre, is led by Anna Pasetto, PhD. Dr Pasetto has extensive expertise in cancer immunology, T-cell-based immunotherapy, TCR discovery, CAR-T and TCR-T development, gene modification, pre-GMP process development and the translation of advanced therapies into GMP manufacturing and clinical trials.

The ACT Centre supports academic, hospital-based and commercial developers throughout the ATMP development pathway. It acts as support infrastructure for projects seeking access to regulatory, scientific, pre-GMP and GMP expertise at Oslo University Hospital.

Services include:

  • early project and feasibility assessment; 
  • advice on ATMP classification and regulatory strategy; 
  • development of manufacturing and quality-control strategies; 
  • process design, optimisation, scale-up and automation; 
  • process and analytical validation planning; 
  • risk assessment and GMP-readiness evaluation; 
  • raw-material and equipment selection; 
  • preparation for technology transfer into GMP manufacturing; 
  • support with project agreements, financing and collaborations; 
  • coordination of pre-GMP, GMP and QC activities; 
  • support for academic–industry partnerships and first-in-human development. 

The ACT Centre’s goal is to reduce the scientific, regulatory and operational barriers between promising research and quality-assured products for clinical trials. 

Location and capacity

The ACT Centre is based in the Research Building at Radiumhospitalet. It uses and coordinates access to several parts of the Department’s infrastructure, rather than occupying one single laboratory area.

The available infrastructure includes:

  • dedicated offices and project-coordination functions; 
  • access to the pre-GMP laboratory; 
  • access to multiple Grade B GMP manufacturing rooms; 
  • access to a dedicated Grade B BSL-2 room for genetically modified products; 
  • access to quality-control, cryopreservation and storage areas; 
  • access to supporting translational and analytical laboratories. 

The Department’s GMP infrastructure includes seven Grade B ex vivo rooms, one Grade B general production room, one dedicated Grade B BSL-2 laboratory, Grade D QC rooms and a classified cryostorage area. 

Main equipment and platforms

Equipment available through ACT-supported projects includes:

  • CliniMACS Prodigy 
  • MaxCyte ExPERT GTx 
  • CTS Rotea 
  • Sepax C-Pro 
  • G-Rex culture systems 
  • automated and manual cell-processing platforms; 
  • biological safety cabinets and unidirectional-airflow workstations; 
  • controlled CO₂ incubators; 
  • closed-system sterile welders and sealers; 
  • controlled-rate freezing systems; 
  • cryogenic storage systems; 
  • NC-200 and NC-202 cell counters; 
  • flow cytometry; 
  • endotoxin testing; 
  • qPCR-based analytical platforms.

 

 
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