Quality Control Laboratory

Expertise and services

The new Quality Control Laboratory is managed by Daniel Lycke Kristiansen, MSc, who has professional experience in pharmaceutical quality control.

The Laboratory is being established as a specialised national QC resource for advanced cell and gene therapies. Its purpose is to provide analytical testing that supports process development, product characterisation, GMP manufacture and future batch release.

Planned services include:

  • rapid sterility testing; 
  • mycoplasma testing by molecular methods; 
  • digital PCR assays; 
  • vector copy number analysis; 
  • residual-vector and residual-cell testing; 
  • identity, purity and potency-related analytical methods; 
  • method development, qualification and validation; 
  • analytical method transfer; 
  • environmental and microbiological testing support; 
  • stability-testing support; 
  • QC documentation and reporting for GMP manufacture; 
  • development of product-specific testing strategies. 

The Laboratory will strengthen Norwegian capacity for ATMP quality control and reduce the need to send critical samples to laboratories abroad, thereby decreasing delays, costs and logistical risks. 

Location and capacity

The QC Laboratory is being established in the John Ugelstad Building, part of the Oslo Cancer Cluster Innovation Park at Campus Radiumhospitalet.

It is planned as a dedicated, GMP-regulated analytical facility with:

  • controlled laboratory rooms; 
  • dedicated microbiology-testing capacity; 
  • molecular-analysis areas; 
  • space for ddPCR and other nucleic-acid-based assays; 
  • an isolator-based area for microbiological testing; 
  • sample-receipt and controlled-storage functions; 
  • supporting office and documentation areas. 

Th laboratory is currently preparing a regulatory package for submission for GMP authorisation. 

Planned main equipment

  • BacT/ALERT system for rapid sterility testing 
  • Droplet digital PCR system 
  • microbiological isolator 
  • automated nucleic-acid extraction equipment 
  • real-time PCR equipment 
  • equipment for mycoplasma testing 
  • biological safety cabinets 
  • laboratory centrifuges 
  • refrigerators, freezers and monitored sample storage 
  • supporting equipment for method development and validation 

Equipment procurement is ongoing, the list will be updated as systems are installed, qualified and approved for use. 

 
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