An alliance between the UK's Procognia and US company Xcellerex promises to provide a new force in contract manufacturing of biologics drugs.
The two companies announced an agreement to provide Procognia's rapid glycoanalysis services to Xcellerex customers. The UK company has developed a technology that enables the assessment of product structure and comparability using an analysis of the glycosylation profile of samples.
Glycosylation - or the pattern of sugar side chains that occur on protein molecules - is an important factor in the manufacture of recombinant drugs as they have an effect on many of the characteristics of the protein. The ability to make proteins with glycosylation patterns that resemble the human form is one of the primary hurdles to overcome when using non-mammalian production systems.
Importantly, Procognia 's U-c fingerprint technology provides a quantitative analysis of the glycans in a protein sample without protein purification or cleavage, thus leaving the sample intact for other investigations. It can also take place in the culture medium, so the sample can be analysed in situ.
Up to 40 protein samples can be analysed in under six hours with minimal 'hands-on' time, claims the UK firm.
"Current tools for analysing glycosylation are not amenable to real-time analysis and monitoring [so] the speed and ease of use of Procognia's technology enables rapid development of biotherapeutics," said the company in a statement.
Xcellerex specialises in offering contract process development and manufacturing technologies for biotherapeutics, vaccines and personalised medicines. It said the integration of the U-c fingerprint technology will allow it to identify and retain the desired glycosylation patterns of products as they undergo process optimisation, scale up for manufacturing and clinical development.
The US company makes use of automation and other technologies in its manufacturing processes and claims it can bring a product from gene to patient in well under one year.