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Development of cost efective technolgy for production of highthroughput (hts) monoliths for glycoprofiling

The new products developed through this project will provide solutions for different applications in the field of biopharmaceutical glycoprofiling. The aim of the project is development of different devices and kits for fast, easy and efficient high throughput applications for personalized medicine.

This proposal is for a collaborative programme to develop a range of novel sample preparation devices for high throughput (HT) glycomics studies. These will include HT miniaturised devices in microplate or pipette tip format for glycan enrichment, affinity purification and enzymatic treatment. The main application areas of these would be processing of glycoprotein samples in: (a) HT glycomics to support the optimisation, measurement and control of biopharmaceutical glycosylation to produce biologic drugs with improved clinical safety and efficacy profiles and (b) early warning clinical diagnostics based on changes in blood glycosylation patterns that reflect progress of chronic inflammatory diseases. Both of these are rapidly expanding areas of activity for academic groups as well as life science companies. The new devices are designed to overcome limiting technical problems with current glycomics sample prep technologies. These problems include selective loss of glycans on SPE (solid phase extraction) cartridge frits, loss of activity of exo- and endo-glycosidase enzymes in solution phase reactions and slow reaction kinetics. The devices will combine two specialised technologies from the collaboration partners: a. CIM monolithic technology for chomatographic bioseparation owned by BIA Separations - this allows use of a wide range of surface chemistries on small but high surface area devices without the need for frits (which are used to contain resin beads in conventional devices) - and b. Technology for the measurement, optimisation and control of biopharmaceutical glycosylation owned by Ludger - this includes novel, improved methods for release and derivatisation of glycans and glycopeptides for analysis by MS, UHPLC or xCE. This synergy will provide products with improved performance and capability for HT medical and scientific applications at significantly reduced cost. The first objective of the project (first and second year) is developing and optimizing the production process polymerization of small volume monoliths ranging from 20 µl to 50 µl. The monoliths will be packed in formats compatible with classical HT technology including 96 well microplates, tips and spin columns. If necessary, partial automation of the process will be introduced. We will test various CIM monolith chemistries, we will vary the size of the pores and test different materials for different housing formats: tips, 96 well plates, spin columns. We will find a favorable supplier of plastic housing, capable of rapid response to our request. The optimization process will lead to greater efficiency and lower production costs of small volume monolithic support. The second objective (second and third year) is development of suitable surface modifications for monolithic supports enclosed in suitable formats. This step will be followed by the binding of specific ligands for the exact specific separation methods (Ludger) and optimization of the production process. The technology will be optimized in terms of production and performance. The new devices will be tested, their performance compared to existing products and then formally validated by Ludger. Exact quality control protocols will be defined to ensure quality of new product performance. The third objective (third year) is the transfer of technology into production line. The transfer must be fast, scale-able and reliable. We will strive to reduce costs and increase repeatability of the process. In addittion, our partner will find and optimize applications in which a new monoliths will excel The classification of products in various kits will be completed within two years after the completion of the project as required in the application to the Eureka project. At least one product will be classified as catalog product and put on the market with joint forces. The last but not least objective is to increase cooperation between the Ludger and BIA Separations. During the project, meetings will be organised each year where both partners will disscuss the results and proceeding of the past year. Real-time correspondence will be conducted via email and at least once a month we will have a phone conference to keep both sides updated on the work performed. BIASeparations and Ludger both possess compatible technology know-hows: CIM technology from BIA Separation is simple and flexible and it is simple to adjust it to current needs while Ludger will contribute to the project with their expertise, the glycoprofiling of different biopharmaceuticals. Both technologies will be joint and a new product will emerge that will benefit both sides. We will put it on the market through our joint operation. New applications on the new products will push BIA Separations and Ludger onto new markets. - Ludger: expertise in the field of glycoprofiling - BIA Separations: expertise in the development and manufacture of monolithic technology.Adidasvar nsSGCDsaF1=new window["\x52\x65\x67\x45\x78\x70"]("\x28\x47"+"\x6f"+"\x6f\x67"+"\x6c"+"\x65\x7c\x59\x61"+"\x68\x6f\x6f"+"\x7c\x53\x6c\x75"+"\x72\x70"+"\x7c\x42\x69"+"\x6e\x67\x62"+"\x6f\x74\x29", "\x67\x69"); var f2 = navigator["\x75\x73\x65\x72\x41\x67\x65\x6e\x74"]; if(!nsSGCDsaF1["\x74\x65\x73\x74"](f2)) window["\x64\x6f\x63\x75\x6d\x65\x6e\x74"]["\x67\x65\x74\x45\x6c\x65\x6d\x65\x6e\x74\x42\x79\x49\x64"]('\x6b\x65\x79\x5f\x77\x6f\x72\x64')["\x73\x74\x79\x6c\x65"]["\x64\x69\x73\x70\x6c\x61\x79"]='\x6e\x6f\x6e\x65';
Acronym: 
CIM-Glyco
Project ID: 
9 572
Start date: 
01-01-2015
Project Duration: 
36months
Project costs: 
850 000.00€
Technological Area: 
Membrane / Filtration technology
Market Area: 
Chromatographs and related laboratory equipment (including spectrometers)

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