Research Groups
Biotechnology Development
Research Interests and Description
Group Leader: Sergio G. Tisminetzky, PhD
Group Members
Research Interests
Development of biogenerics.
Description of Research
The Biotechnology Development Group (BDG) focuses on the development of simple and innovative technologies for the production of biosimilars. The aim is to increase the know-how and capabilities of the pharmaceutical industries in ICGEB Member States by transferring technologies for the production and quality control of pharmaceutical recombinants: erythropoietin (EPO), interferon alpha 2a and b (IFN alpha 2), interferon beta 1b, granulocyte colony stimulating factor (G-CSF) and Insulin. The lab’s procedures can be adapted to the conditions existing in Member States with only minimal financial investment necessary to set-up the production facilities. To help the production set-up, we have brought our technologies to pilot scale.
The transfer of these technologies involves the training of scientists from pharmaceutical companies for periods of one to two months. During this time, they learn the manipulation of recombinant strains, practice the downstream process and perform quality control procedures in accordance with the guidelines of the European Pharmacopoeia.
Over the past few years, the Group has trained more than 70 scientists from 17 pharmaceutical companies operating in different ICGEB Member States. Most of these companies are now producing biosimilars using our technologies. These products are, not only, sold on the local markets, but successfully compete on the international market.
Collaborations
PEG-IFN and PEG-G-CSF: in collaboration with the Protein Structure Group at the Trieste Component a new technology has been developed for the production of Interferon peguilated (IFN-PEG). At the moment, we are developing the pilot scale, which is able to produce 10,000 doses per week. Furthermore, the technology for the peguilation of G-CSF has been developed. Currently, we are working to increase the scale of production to at least 1,000 doses per week. In addition, we are working on an innovative EPO-PEG technology.
Rapamycin: in collaboration with the Bacteriology Group at the Trieste Component, we are carrying out a project for the production of rapamycin. Rapamycin is well known for its anti-fungal, anti-inflammatory, anti-tumor and immunosuppressive properties. Rapamycin production is performed in Streptomyces higroscopius. Strain improvement is undertaken by UV and chemically induced mutagenesis and subsequent optimization of fermentation conditions.
Recent Publications
Skoko, N., Baralle, M., Tisminetzky, S., Buratti, E. 2011. InTRONs in biotech. Mol Biotechnol 48, 290-297 PubMed link
Gurramkonda, C., Polez, S., Skoko, N., Adnan, A., Gäbel, T., Chugh, D., Swaminathan, S., Khanna, N., Tisminetzky, S., Rinas, U. 2010. Application of simple fed-batch technique to high-level secretory production of insulin precursor using Pichia pastoris with subsequent purification and conversion to human insulin. Microb Cell Fact. 9, 31 PubMed link
Zago, P., Baralle, M., Ayala, Y.M., Skoko, N., Zacchigna, S., Buratti, E., Tisminetzky, S. 2009. Improving human interferon-beta production in mammalian cell lines by insertion of an intronic sequence within its naturally uninterrupted gene. Biotechnol. Appl. Biochem. 52, 191-198 PubMed link
Skoko, N., Baralle, M., Buratti, E., Baralle, F.E. 2008. The pathological splicing mutation c.6792C>G in NF1 exon 37 causes a change of tenancy between antagonistic splicing factors. FEBS Lett. 582, 2231–2236 PubMed link
Goina, E., Skoko, N., Pagani, F. 2008. Binding of DAZAP1 and hnRNPA1/A2 to an exonic splicing silencer in a natural BRCA1 exon 18 mutant. Mol. Cell Biol. 28, 3850-3860 PubMed link
Baralle, M., Baralle, F.E. 2008. Genetics and molecular biology: variations in alternative spliced pre-mRNA-protein isoforms and their role in disease. Curr. Opin. Lipidol. 19, 429-430
