Research Groups

Biotechnology Development

Research Interests and Description

Group Leader: Sergio 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 labs procedures can be adapted to the conditions existing in Member States with only minimal financial investments 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 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 also successfully compete on the international market.

Collaborations

PEG-IFN and PEG-G-CSF: The Protein Structure Group (PSG) at the Trieste Component has developed a new technology for the production of Interferon peguilated (IFN-PEG). In 2005 two pharmaceutical companies have learnt this technology. The PSG is also developing the technology for the peguilation of G-CSF and new methods for the activation of PEG. Presently, we are working on an innovative EPO-PEG technology.

Recent Publications

Dominissini, S., Buratti, E., Bembi, B., Baralle, M., Pittis, M.G. 2006. Characterisation of two novel GBA mutations causing Gaucher disease that lead to aberrant RNA species by using functional splicing assays. Hum. Mutat. 27, 119

Senerovic, L., Stankovic, N., Spizzo, P., Basso, A., Gardossi, L., Vasiljevic, B., Ljubijankic, G., Tisminetzky, S., Degrassi, G. 2006. High-level production and covalent immobilisation of Providencia rettgeri penicillin G acylase (PAC) from recombinant Pichia pastoris for the development of a novel and stable biocatalyst of industrial applicability. Biotechnol. Bioeng. 93, 344-354

Baralle, D., Baralle, M. 2005. Splicing in action: assessing disease causing sequence changes. J. Med. Genet. 42, 737-748

Buratti, E., Brindisi, A., Giombi, M., Tisminetzky, S., Ayala, Y.M., Baralle, F.E. 2005. TDP-43 binds heterogeneous nuclear ribonucleoprotein A/B through its C-terminal tail: an important region for the inhibition of cystic fibrosis transmembrane conductance regulator exon 9 splicing. J. Biol. Chem. 280, 37572-37584