iBET’s Bioproduction Unit offers R&D services for virus-based biopharmaceuticals production
With 30 years of experience and equipped with state-of-the-art equipment, iBET is the ideal partner for production and purification of replicative virus and non-replicative viral particles
FULL RANGE SERVICE: FROM GENE TO PROTEIN
iBET’s Bioproduction Unit offers late-stage R&D, scale up and technology transfer services, from small-scale feasibility studies to large-scale production and purification, and technology transfer to GMP (provided through GenIbet, www.genibet.com). At iBET a full set of instruments and strategies have been established to develop integrated bioprocesses and analytical methods for the production, purification and characterization of virus-based biopharmaceuticals. The infrastructure is located in a BSL2 facility allowing scale-up to 50 L.
- Gene therapy viral vectors:
- Virus-like particles (VLPs):
- Vectored vaccines:
- Cell lines:
- Mammalian cells: HEK293, PerC6, CAP, Caco2, MRC-5, Sp2/0, BAE, Vero, MDCK, DK, CHO, A549, ExpiCHO-S™ and Expi293F™;
- Insect cells: Sf-9, Sf-21, High Five, ExpiSf9™ and super Sf9.
- Expression systems:
- Stable expression in mammalian and insect cells;
- Transient expression, e.g. transfection and insect cells-baculovirus expression vector system (IC-BEVS).
- Culture systems:
- Anchorage dependent cells, e.g. microcarrier technology in bioreactors;
- Single cell suspension.
- Bioreactor systems/types and operation modes:
- Stainless-steel and single-use bioreactors;
- Environmentally controlled stirred tank (0.5 L to 50 L) and Wave bioreactors (0.5 L to 25 L);
- Batch, Fed-batch, perfusion and continuous.
- Purification of secreted and intracellular viral particles;
- Membrane technology: ÄKTA Crossflow – scalable, ultrafiltration systems;
- Chromatography: ÄKTA Platform Technology (Pure, Avant and Pilot);
- Continuous and multi-column chromatographic purification systems.
- Impurities: DNA, Host Cell Protein, product related impurities (e.g. empty capsids);
- Titration protocols for infectious viral particles, e.g. flow cytometry, TCID50, plaque assay and MTT assay;
- RT-qPCR for genome-containing viral particles and for adventitious viruses;
- Capillary Electrophoresis;
- ELISA for transgene expression and for process contaminant detection;
- Nanoparticle tracking analysis (using NanoSight®) for physical viral particles quantification;
- Mass spectrometry;
- Transmission electron microscopy (negative staining and immunogold labelling);
- Dynamic light scattering;
- Surface plasmon resonance;
- Bio-layer interferometry technology;
- Tunable Resistive Pulse Sensing (qNANO);
- Analytical chromatographic methods for purity assessment;
- Cell-based potency assays.
At iBET, we develop mammalian and insect cell lines for stable expression of virus-based biopharmaceuticals using advanced molecular biotechnology and synthetic biology tools (e.g. recombinase mediated cassette exchange (RMCE), metabolic engineering and CRISPR-CAS9). We also develop computational biology methods (e.g. dielectric and fluorescence spectroscopy, holographic imaging) for on-line monitoring of cell concentration and viral particles production.