Pre-GMP Facility

Expertise and services

The Pre-GMP Facility is managed by Thomas Nesset, MSc, who has practical experience in ATMP development and manufacturing within the ACT Centre. The facility provides a controlled environment for projects that are progressing from academic research towards GMP manufacturing.

The Facility specialises in phase-appropriate process development, equipment and prototypes testing, scale-up and preparation for technology transfer. It is designed to reproduce essential features of GMP manufacturing while allowing greater flexibility and lower development costs than a licensed GMP production environment.

Services include:

  • cell-therapy process development and optimisation; 
  • scale-up and scale-out studies; 
  • development of open, closed and automated manufacturing processes; 
  • assessment of critical raw materials; 
  • testing of GMP-comparable reagents and consumables; 
  • evaluation and implementation of new equipment; 
  • development of in-process controls and sampling strategies; 
  • development of preliminary analytical and QC methods; 
  • process-risk assessment; 
  • preparation of development reports, draft batch records and SOPs; 
  • operator training and practical GMP preparation; 
  • engineering and pilot-scale runs; 
  • preparation for technology transfer to the GMP facility; 
  • technical support for CAR-T, TCR-T, NK-cell, dendritic-cell, stem-cell and other ATMP projects. 

The facility acts as a safety net before projects commit to costly GMP manufacturing, helping identify technical, material, documentation and quality risks at an earlier stage. 

Location and capacity

The Pre-GMP Facility is located close to the Department’s GMP manufacturing area, with one room in the Research Building at Radiumhospitalet and one new room at the John Ugelstad Building. This proximity facilitates staff interaction and technology transfer between development and GMP operations. 

It includes controlled laboratory space with:

  • restricted access; 
  • dedicated cell-culture capacity; 
  • work areas for manual and automated processing; 
  • biological safety cabinets; 
  • incubators and supporting laboratory equipment; 
  • equipment selected or configured to correspond with GMP platforms; 
  • separate arrangements for work involving viral vectors or genetically modified cells, where required. 

Main equipment

  • MaxCyte ExPERT GTx 
  • NucleoCounter NC-202 
  • biological safety cabinets 
  • CO₂ incubators 
  • centrifuges 
  • cell-culture and expansion systems 
  • equipment for closed-system processing 
  • sterile welders and sealers 
  • refrigerators and freezers 
  • microscopes 
  • supporting equipment for sampling and analytical development 
  • access to cell-processing platforms harmonised with the GMP facility 
  • access, depending on the project, to Rotea, Prodigy, G-Rex and related manufacturing platforms
 
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