iBET’s Bioproduction Unit offers R&D services for recombinant proteins production
With 30 years of experience and equipped with state-of-the-art equipment, iBET is the ideal partner for production of recombinant proteins, virus-based biopharmaceuticals, antibodies, enzymes and protein complexes
FULL RANGE SERVICE: FROM GENE TO PROTEIN
iBET’s Bioproduction Unit offers late-stage R&D, scale up and technology transfer services, from molecular biology to expression and purification (small- to pilot-scale), product characterization and purity assessment, process monitoring and control, and technology transfer. All activities are carried out in BSL2 labs and certified according to GLP standards, and if required cGMP production may be provided through GenIbet (www.genibet.com).
- Reverse translation of the protein of interest;
- Host specific codon optimization;
- Vector construction;
- Special features, e.g., inclusion of tags for purification, insertion of protease signal for tag removal, signal peptides for secretion.
- 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;
- Bacteria: E. coli;
- Yeast: Pichia Pastoris, S.cerevisiae.
- Expression systems:
- Stable expression in mammalian and insect cells, bacteria and yeast;
- Transient expression, e.g. transfection and insect cells-baculovirus expression vector system (IC-BEVS).
- 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 targets (tagged or untagged);
- Purification of proteins from inclusion bodies, including refolding methodologies;
- Membrane technology: ÄKTA Crossflow – scalable, ultrafiltration systems;
- Chromatography: ÄKTA Platform Technology (Avant, Pure and Pilot).
Product characterization and purity assessment
- Concentration: A280, BCA and HPLC;
- Purity: MS, HPLC, gel electrophoresis, Western Blot, endotoxin level, host DNA and protein quantification, and sterility tests;
- Functional assays: ELISA and product specific cell-based assays;
- Virus titration: infectious (e.g. MTT assay) and total (e.g. ELISA) viral particle quantification;
- Stability testing: HPLC-SEC, dynamic light scattering, thermal-shift assay;
- Peptide mass fingerprinting and post-translational modifications profiling (e.g., glycosylation and phosphorylation): MS;
- Aggregation and refolding: SEC and RP chromatography.
Process monitoring and control
- Bioreactor monitoring and control: O2, CO2, pH, temperature, gravimetric control for perfusion and Fed-batch;
- Shake flasks (up to 500 mL) monitoring: pH and O2 (with PreSens);
- At-line analysis: cell concentration and viability (Cedex HiRes and ViCell), metabolites (Cedex Bio);
- UBICON system for process control and supervision (the basis for cGMP dossiers).
- Technology transfer for CMOs in all steps of process development, including SOPs and batch record writing assistance, and shadowing of key operations.