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Retroviral vectors
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Process development
- Consulting
- Selection of raw material
- Vector optimisation
- Assay development & qualification
- Process adaptation & validation
- Preparation of authority communication
Preclinic
- Consulting
- Production of preclinical vector batches
- Development of functional in vitro assays
- Preclinical in vitro testing (according to GLP standard)
Early clinical development (phase I/II)
- Consulting
- Application for manufacturing license
- Establishment and characterisation of producer cell lines (MCB & WCB)
- Cell banking
- Production of clinical grade vector batches (up to 350 litres), also concentrated
- QC analytic of cell banks and vector stocks (safety & efficacy testing)
- Molecular patient monitoring
Late clinical development (phase II/III)
- Production of clinical grade vector batches (up to 350 litres), also concentrated
- QC analytic of cell banks and vector stocks (safety & efficacy testing)
- Molecular patient monitoring
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