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