Research Groups

Biotechnology Development

Research Interests and Description

Group Leader:
Marco Baralle, PhD

Group Members

Research Interests

Development of biosimilars and small molecules. Study of modulators of TDP43 aggregation.

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 generic biologics in pilot scale of the technologies for erythropoietin (EPO), interferon alpha 2a and b (IFN alpha 2), interferon beta 1b, granulocyte colony stimulating factor (G-CSF) and Insulin. The group has also developed PEGylation technologies in collaboration with the Protein Structure Group for IFN, GCSF and EPO.

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. 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 78 scientists from 19 different ICGEB Member States. Most of these from companies that 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 Rapamycin strain development, small molecule chemistry development and innovative chemical modification of EPO. Finally, taking advantage of a model developed by the Molecular Pathology Group regarding TDP43 aggregation observed in patients with amyotrophic lateral sclerosis we have set up a research project aimed to study the modulators of TDP43 aggregation. 

A screen of chemical compounds are being tested for their effect as clearance agents and consequently potential use in neurodegenerative diseases therapies with initial results showing some compounds able to reduce aggregation by more than 50% (shown in Figure).

Recent Publications

Menvielle, J.P., Safini, N., Tisminetzky, S.G., Skoko, N. 2012. Dual Role of Dextran Sulfate 5000 Da as Anti-Apoptotic and Pro-Autophagy Agent. Mol Biotechnol. [Epub ahead of print] PubMed link 

Skoko, N., Baralle, M., Tisminetzky, S., Buratti, E. 2011. InTRONs in biotech. Mol Biotechnol 48, 290-297 PubMed link

Ayala, Y.M., De Conti, L., Avendaño-Vázquez, S.E., Dhir, A., Romano, M., D'Ambrogio, A., Tollervey, J., Ule, J., Baralle, M., Buratti, E., Baralle, F.E. 2011. TDP-43 regulates its mRNA levels through a negative feedback loop. EMBO J 30, 277-288 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

 

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AREA Science Park
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34149 Trieste, ITALY
Tel: +39-040-37571
Fax: +39-040-226555
icgebicgeb.org
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