Investigating Novel Valuable Bio-therapeutics and Expression Systems

The production of IgG’s, whose market size reaches up €100 billion per year, has revolutionized the biotechnology industry with products used for the treatment of cancer and immune disorders. The success of standard IgG’s built over years of optimization, has led to high expectations for novel recombinant proteins (rPs), so called as the “third generation” biopharmaceuticals. Timeframes, stakeholders and commercial pressures are different to those of a decade ago and the manufacture of new rPs is challenging. The promise of commercial and clinical returns from new rPs, such as fusion proteins (for novel disease targeting), IgA (the most abundant Ig isoform, for treatment of IgA deficiencies and cancer) and secreted mucins (for therapy and vaccinology) is obvious. However, these are unexpectedly difficult to manufacture, with unpredictable failures to generate any (or enough) product. Studies accessible to scrutiny indicate that unpredictable limitations occur at the level of translation, folding and post-translational processing (especially N- and O-glycosylation).

Innovate, which is funded by ERA-NET, will develop new animal and plant cell and glycosylation expression technologies. Also, optimized bioprocesses will be established for the production of these difficult to express and novel rPs. These, ultimately, have the potential to open up new targets and treatments that resist current therapies. Six European partners, enclosing eminent research group’s together with industrial partners, are involved in this project: University of Kent, University of Manchester, Fraunhofer Institute for Molecular Biology and Applied Ecology, Lonza Biologics, ITQB-NOVA and iBET. iBET is strongly engaged in the Innovate project, being responsible for the development of a proteomics platform for rPs in-depth characterization. Additionally, stringent downstream processes for the purification of the generated rPs are being developed.