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Going after glycobiology
DUBLIN—Continuing its quest to work with world-leading experts to create the tools and pathways needed to develop safer, more effective drugs with reduced time-to-market, GE Healthcare Life Sciences has tapped the services of Ireland's National Institute for Bioprocessing Research and Training (NIBRT) to drive the development of new, biologically relevant and fully characterized binding assays for measuring antibody activity.
According to the partners, developing these assays is a critical step in the design and manufacture of effective monoclonal antibody-based therapies, protein-based drugs that are increasingly used to treat diseases such as cancer, rheumatoid arthritis and multiple sclerosis. Moreover, as regulatory agencies continue to demand more detailed characterization of new biotherapeutic biological properties, it will be increasingly important to have assays that are reproducible, sensitive, accurate and robust, the partners say.
"Our goal here is to use the best global experts to develop state-of-the-art technology that can help the biopharma industry develop new drugs, reduce cost and improve quality," says Dr. Lotta Ljungqvist, head of research and development for the BioTechnologies business of GE Healthcare Life Sciences.
Located in a new, world-class facility in Dublin, the NIBRT bills itself as a "global center of excellence for training and research in bioprocessing." The institute is based on an innovative collaboration between University College Dublin, Trinity College Dublin, Dublin City University and the Institute of Technology, Sligo. The NIBRT was primarily funded by the Irish government through Ireland's inward investment promotion agency, Industrial Development Agency (IDA) Ireland, which is responsible for the attraction and development of foreign investment in Ireland.
The institute supports the bioprocessing industry by providing trainees with an environment that replicates the modern industrial bioprocessing facility and undertaking leading-edge research collaborations with industry in key areas of bioprocessing. The NIBRT's extensive partner list includes Becton, Dickinson & Co., Intertek, Janssen Biologics, Eli Lilly & Co., Merck & Co. Inc., Pfizer Inc., Roche and Shire.
Its latest collaboration, with GE Healthcare, evolved from the company's interest in the expertise of Prof. Pauline Rudd, a specialist in the field of glycobiology for more than 25 years. Glycobiology deals with the roles of sugars in biological systems. The glycan processing pathways involve 5 percent or more of the genome and at least 600 proteins.
Many new biotherapeutics contain glycans, and the sugars can influence the safety and efficacy of drugs such as erythropoietin and monoclonal antibodies.
"When developing a drug, it is very important to understand the roles of the sugars and have very robust technologies to quantitatively analyze them," says Rudd.
Spanning most areas of biology, glycobiology has allowed Rudd to work on projects as diverse as prion proteins, HIV, autoimmune disease, the T-cell synapse, MHCI and immunoglobins from human and other species. This work led Rudd and her colleagues to develop the tools needed for testing antibody effector function— tools that are crucial in the testing of future antibodies for efficacy and potential side effects.
Rudd's group has developed state-of-the-art glycan analysis tools that can be applied to both fundamental and applied research. The robotic, 96- well plate analytical platform, which allowed the first-ever correlations to be made between the genome and the plasma glycome in a GWAS study, is also designed to handle multiple samples ranging from process development to product analysis. The hardware is linked to NIBRT software and experimental databases to assist with data interpretation.
In this partnership, these tools and expertise will be married with GE Healthcare's Biacore SPR technology, a technology for monitoring molecular interactions as they occur by following changes in mass concentration close to a sensor surface.
"Biacore is a technique to understand the binding between two molecules," Ljungqvist explains. "It is based on SPR and is used successfully in screening candidates in the early stages of development. It provides a lot of information on the same assay, and more data generated in a shorter timeframe."
The collaboration will ease some of the current challenges with using cell-based assays, she adds: "Cell-based assays use cells as one of their reagents. Often it is difficult to access these cells, and they can be more tricky to handle. You must try to make a decision on the predicted half-life of a drug based on an assay with high variability. They are also very time- and labor-consuming. A much easier and quicker method is using characterized reagents and biochemical assays. You get your information with less variability when well-characterized reagents are used. You can do more of these assays, more quickly, and generate more information earlier on."
"Increased robustness and decreased costs are appealing features of any assay, and the added benefit of strong correlation with cell-based assays indicates a very strong potential for the Fc receptor platform with industry," adds Dr. Eoin Cosgrave, a postdoctoral researcher with the NIBRT and the lead scientist in the collaboration.
GE Healthcare and the NIBRT are investing $500,000 in the first year of the project, which is planned to run for two years.
GE Healthcare executes recombinant Protein L license from Affitech
COPENHAGEN, DENMARK—GE Healthcare Life Sciences also announced last month an exclusive license for the worldwide marketing and sales of products containing recombinant Protein L, granted by Affitech in a patent and know-how license agreement.
Under the terms of the agreement, GE Healthcare will pay Affitech a royalty of the net sales of all related products sold by GE Healthcare.
Martin Welschof, managing director of Affitech said in a press release that Protein L has proved to be the only naturally occurring affinity protein useful for working with both non-protein A binding antibodies and antibody fragments.
"This is an important step forward for GE Healthcare Life Sciences and will enable us to develop new technologies to help solve some of the most difficult challenges faced by our customers in biopharmaceutical manufacturing and in protein science research," added Catarina Flyborg, general manager of BioProcess products at GE Healthcare Life Sciences.