FP7-SME-2011 - Development of a rapid cellular characterisation technology for use in the bioprocessing industry (PM-CELLS )
This project is being delivered by the researchers in ITT, led by Dr. Joanna Tierney. Dr Tierney is the co-ordinator of this project and brings her extensive expertise in the use of cellular characterisation technology to this project, as well as considerable experience in the life sciences sector. The PM-CELL project is worth €1.5 million and seeks to develop a predictive assay designed for manufacturing processes of therapeutic monoclonal antibodies synthesised by mammalian cell lines.
The PM-CELL consortium involves eight European partners of four SMEs and four RTD (Research and Technological Development) performers. The RTD performers are Institute Technology Tralee (Ireland), University of Sheffield, UK, University of Limerick, Ireland, Veterinary Laboratory Agency, UK. The SMEs include Technopath (Ireland), IUL Instruments GmbH (Germany), Dorte Egelund ApS (Denmark) and Euformatics Oy (Finland). The project idea, conceived by the SME Technopath, addresses the issue of the real requirement and strong market demand for rapid characterisation testing methods.
The annual global biopharmaceutical market is currently valued at $50 billion (€37.4 billion), projected to reach $70 billion (€52.4 billion) by the end of the decade. Biopharmaceuticals, consisting of monoclonal antibodies and recombinant proteins have been established as innovative and effective treatments for a range of diseases and conditions, including cancer, autoimmune disease, viral infections, infertility and many others and this is why they are regarded as extremely high-value products. Biopharmaceuticals are derived from living sources including bacteria, yeast and mammalian cells with the majority (over 60%) produced in mammalian cells as they allow for the correct processing and formation of the product which cannot be achieved in other eukaryotic or bacterial hosts.
The demand for cell-derived biopharmaceutical products is increasing. This demand is caused not only by the fact that there are an estimated 600 biopharmaceuticals currently in the therapeutic pipeline but also because patent expiry on many big-selling popular branded products is giving way to a biosimilar market. There is also the constant drive to reduce cost to the patient and on the horizon is the advent of stem cell therapy products, expected to revolutionise many treatment options. Dr. Tierney sees these demands as crucial: 'As these factors are steering the development of high-yielding mammalian cell culture processes, the development of more efficient methods of cell line characterisation technologies in parallel is paramount. This is the market opportunity that the PM-CELL product responds to.'