Biotechnology Development

MEDICAL BIOTECHNOLOGY / Biotherapeutic Products

Research Interests

Development of biotherapeutic products.

Description of Research

The Biotechnology Development Unit (BDU) focuses on the development of technologies for the production of biotherapeutic products. 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 biopharmaceuticals from lab to pilot scale for Erythropoietin (EPO), Interferon alpha 2a and 2b (IFN alpha 2), Interferon beta 1b, Granulocyte Colony Stimulating Factor (G-CSF), Insulin, Growth Hormone. The Group has also developed PEGylation technologies for IFN, GCSF and EPO as well as fatty acids-protein conjugation technologies for long-lasting insulins.

The lab’s procedures can be adapted to the conditions existing in Member States with a financial investment necessary to set-up the production facilities. The transfer of these technologies involves the training of scientists from pharmaceutical companies for periods of four to five weeks. 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 100 scientists from 19 different ICGEB Member States. Most of these companies are now producing biosimilars using our technologies. Not only are these products sold on the local markets, they successfully compete on the international market.

Current research in the Group focuses on process development for production of GLP-1 receptor agonist Liraglutide, soluble TNF receptor fusion protein Etanercept and antibody fragment Certolizumab pegol.

Finally, we have set up a research project aimed to study miRNAs able to enhance production of recombinant proteins of pharmaceutical interest in CHO cells.

Recent Publications

Caronni, N., Simoncello, F., Stafetta, F., Guarnaccia, C., Ruiz-Moreno, J.S., Opitz, B., Galli, T., Proux-Gillardeaux, V., Benvenuti, F. 2018. Downregulation of membrane trafficking proteins and lactate conditioning determine loss of dendritic cell function in lung cancer. Cancer Res pii: canres.1307.2017. doi:10.1158/0008-5472.CAN-17-1307. [Epub ahead of print] Pubmed link

Polez, S., Origi, D., Zahariev, S., Guarnaccia, C., Tisminetzky, S.G., Skoko N., Baralle M. 2016. A simplified and efficient process for insulin production in Pichia pastoris PLos One, 11, doi: 10.1371/journal.pone.0167207 PubMed link

Zampieri, D., Mamolo, M.G., Vio, L., Romano, M., Skoko, N., Baralle, M., Pau, V., De Logu, A. 2016. Antimycobacterial activity of new N1-[1-[1-aryl-3-[4-(1H-imidazol-1-yl)phenyl]-3-oxo]propyl]-pyridine-2-carboxamidrazone derivatives. Bioorganic Medicinal Chem Letts, 26, 3287-90, doi: 10.1016/j.bmcl.2016.05.053 PubMed link

Menvielle J.P., Safini, N., Tisminetzky S.G., Skoko N. 2013. Dual role of dextran sulphate 5000 Da as anti-apoptotic and pro-autophagy agent. Mol Biotechnol 54, 711-720 PubMed link

Skoko, N., Baralle, M., Tisminetzky, S., Buratti,  E. 2011. InTRONs in Biotech, Review, 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. Microbial Cell Factories 9, 31 PubMed link