PoreSelect · Macroporous Polymer Monoliths as a Low-Cost Bioanalytical Platform for Biopharmaceutical Glycoprotein

Macroporous Polymer Monoliths as a Low-Cost Bioanalytical Platform for Biopharmaceutical Glycoprotein

Glycoprotein therapeutics are widely seen as the next generation of drugs. 80% of new therapeutic drugs in phase 3 development are ‘biologics’. However, the early detection of critical glycosylation changes in biopharma production (i.e. in the drug producing cells) and the rapid and sensitive identification and separation of closely related protein-drug glycoforms presents an industry wide problem. Current technology: Traditional chromatographic methods, such as ion exchange chromatography, size exclusion chromatography and hydrophobic interaction chromatography are used to separate glycoforms but all of them lack the selectivity required to separate and identify closely related glycoproteins or glycoforms. These critical variations are usually a matter of small differences in neutral glycans or alpha- or beta- forms of sugars. Presently, such glycoprotein analyses and separations is difficult, and is carried out by reverse phase high performance liquid chromatography (RP-HPLC) followed by high-end mass spectrometry, which is relatively expensive, time consuming and requires a technical expert specialist. The entire industry has a requirement for a relatively easy, fast and sensitive system for glycoproprotein analysis and separation. This project aimed to develop a low-cost and easy-to-produce glycopeptide separation platform. This was based on producing highly porous materials that are obtained from the fast and scalable polymerisation from high internal phase emulsions (PolyHIPEs) and the subsequent functionalisation of reactive functional groups. The latter is employed for the conjugation with novel recombinant proteins, called lectins that have very selective carbohydrate-binding properties. The separation of closely related glycoproteins will be investigated. Moreover, the integration of the lectin conjugated porous polymers into a device format will be investigated. This is a highly interdisciplinary project at the interface of polymer and material science, biotechnology and separation science.

Data: CORDIS, © European Union