Medical Biotechnology

Biotherapeutic Products

The Biotechnology Development Unit (BDU) in Trieste (Skoko) focuses on the development of technologies for the production of biopharmaceuticals using three main expression systems: bacteria, yeast and mammalian cells. Techniques include the most comprehensive range of activities in bioprocessing such as upstream-downstream operations and quality control analysis following European Pharmacopoeia monographs. The BDU collaborates with pharmaceutical industries to transfer know-how to increase their capacity and reduce cost in ICGEB Member States.

Highlights

The BDU personnel have provided multiple training and technology transfers for the production of insulin and growth hormone to industry. The Unit is currently working on the development of production and quality control tests for the biosimilar Trastuzumab and has made a significant advance in identifying the miRNAs capable of enhancing production of biopharmaceuticals in CHO cells. The Unit has been working on a detailed project design of a new infrastructure dedicated to R&D bioprocesses in line with the principles of Good Laboratory/Good Manufacturing Practices. Such scientific support represents a significant incentive for the development of biosimilars both locally and internationally.