The SIDUS® platform combines our biological materials (cell lines and vector systems) with our in-depth experience and complete protocol systems for manufacturing viral vector-based vaccine and gene therapy products.
The mammalian cells commonly used for viral vector manufacturing are Vero cells (for measles and VSV vectors) and HEK293 cells (for AAV, adeno and lentiviral vectors) as well as derivatives thereof. For both cell types, we have generated research-grade cell banks (R&D) and fully tested and released master cell banks (GMP). Next to these parental cell lines, we have subcloned versions of Vero cells that allow the production of substantially higher amounts of virus particles per cell for certain viruses. In addition, we have also developed engineered versions of HEK293 cells that allow for stable, high yield manufacturing of infectious virus particles. For instance, stable expression of certain adenoviral vector-derived proteins in HEK293 has been able to provide a cell platform capable of supporting the robust growth of diverse human and non-human adenoviral serotypes. Further addition of regulatory elements that control transgene expression (e.g. tetracycline operon) into the engineered HEK293 cells ensures production of adenoviral vectors carrying transgenes whose protein products may otherwise interfere with cell growth or vector assembly. This results in high yields in engineered HEK293 cells.
We have access to several plasmid stocks, for instance, to generate lentiviral, measles, and diverse adenoviral vectors (both human and non-human serotypes). Using the accompanying digital viral vector maps, we can design and synthesize viral vector genomes to ensure high expression of gene(s) of interest, expressed from a viral vector backbone. As such, diverse viral vectors can be ordered for pre-clinical research for which we can deliver high quality research batches of vectors either carrying marker genes (e.g. LacZ, luciferase and GFP) or custom-made target therapeutic genes. Our SIDUS® know-how is also anchored in test protocols specifically and non-specifically for viral vectors. This expedites the progression of projects as important tests to verify in-process results from our USP and DSP teams are available in-house. With the SIDUS® technology, we have successfully brought viral vector products based on adenovirus, lentivirus, and measles from lab bench to clinic. To summarize, we have extensive experience to design vector genome modifications (molecular biology), we have optimized transfection and infection procedures for small- and large-scale production, we have manufactured hundreds of high-quality research batches for pre-clinical studies, and we have delivered multiple viral vector-based products for phase I and phase II clinical studies in both EU and USA markets.