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Gene Therapy

We have specific experiences and capabilities relating to a large number of therapeutic areas.

What we offer

Unilabs has experience in providing services within Gene Therapy studies. Examples include – but are not limited to:

  • Bioanalytical partner for the first registered European gene therapy drug
  • GMO approved laboratory facilities
  • Testing of immunogenicity directed towards viral vectors (AAV)
  • Molecular genetic diagnostics
  • Method development and validation according to regulatory guidelines
  • Regulatory consultancy in relation to method validation
  • Easy transfer of projects between different Centres of Excellence (CoE) via our individually assigned project managers. CoE’s include immunoassays, molecular diagnostics, flow cytometry, histopathology and medical imaging
  • Management of centralised and de-centralised Companion Diagnostic (CDx) testing and global, customised logistics
  • Customisation of every project – no matter the number of patients. This ensures you get exactly what is required for the project without unnecessary expenses
Gene Therapy

GMO approved laboratory facilities

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