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
GMO approved laboratory facilities