The Biotechnology Development Unit (BDU) in Trieste (Dr. Skoko) focuses on the development of the sustainable technologies for the production of biopharmaceuticals. The aim is to increase the capabilities of the pharmaceutical industries in the ICGEB Member States by training bioprocessing professionals and transferring knowledge. Trainings include the manipulation of recombinant cells, downstream process and quality control procedures for 14 biologics, such as filgrastim, erythropoietin, growth hormone and insulins. Availability of this kind of scientific support in the ICGEB represents a significant incentive for the development of biosimilars locally and internationally and speed up the biopharma ecosystems in emerging markets.
Highlights
During 2020, in order to meet the growing demand for distance learning, the BDU designed online training modules that cover the entire production process from the cell to the purified product. This rich video-based platform can deliver training effectively everywhere, as an alternative to standard in-house training. BDU signed several technical assistance agreements for the production of insulin based on this video training. In the course of 2020, the ICGEB is creating a new pharma-compliant facility for biosimilars development. BDU is now intensively developing the structure and documentation for the Good Manufacturing Practice (GMP) certified Quality Control lab. BDU successfully implemented an Electronic Lab Notebook for easy lab data management in a GLP/GMP-compliant manner. The new facility will help us to continue to support the global harmonization of quality specifications for biologics. This expansion will also allow the development of similar antibody-based therapeutics. A key focus is the development of the technologies for the production of monoclonal antibodies trastuzumab and tocilizumab for the treatment of breast cancer and arthritis. Furthermore, in response to the coronavirus pandemic, BDU prepared stable transfected CHO cell lines for the production of the spike protein as well as a SIP recombinant antibody for the serology SARS-CoV-2 testing.
