DUBLIN—Continuing its quest to work with world-leadingexperts to create the tools and pathways needed to develop safer, moreeffective drugs with reduced time-to-market, GE Healthcare Life Sciences hastapped the services of Ireland's National Institute for Bioprocessing Researchand Training (NIBRT) to drive the development of new, biologically relevant andfully characterized binding assays for measuring antibody activity.
According to the partners, developing these assays is acritical step in the design and manufacture of effective monoclonalantibody-based therapies, protein-based drugs that are increasingly used totreat diseases such as cancer, rheumatoid arthritis and multiple sclerosis.Moreover, as regulatory agencies continue to demand more detailedcharacterization of new biotherapeutic biological properties, it will beincreasingly 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 developstate-of-the-art technology that can help the biopharma industry develop newdrugs, reduce cost and improve quality," says Dr. Lotta Ljungqvist, head of researchand development for the BioTechnologies business of GE Healthcare LifeSciences.
Located in a new, world-class facility in Dublin, the NIBRTbills itself as a "global center of excellence for training and research inbioprocessing." The institute is based on an innovative collaboration betweenUniversity College Dublin, Trinity College Dublin, Dublin City University andthe Institute of Technology, Sligo. The NIBRT was primarily funded by the Irishgovernment through Ireland's inward investment promotion agency, IndustrialDevelopment Agency (IDA) Ireland, which is responsible for the attraction anddevelopment of foreign investment in Ireland.
The institute supports the bioprocessing industry byproviding trainees with an environment that replicates the modern industrialbioprocessing facility and undertaking leading-edge research collaborationswith industry in key areas of bioprocessing. The NIBRT's extensive partner listincludes Becton, Dickinson & Co., Intertek, Janssen Biologics, Eli Lilly& Co., Merck & Co. Inc., Pfizer Inc., Roche and Shire.
Its latest collaboration, with GE Healthcare, evolved fromthe company's interest in the expertise of Prof. Pauline Rudd, a specialist inthe field of glycobiology for more than 25 years. Glycobiology deals with theroles of sugars in biological systems. The glycan processing pathways involve 5percent or more of the genome and at least 600 proteins.
Many new biotherapeutics contain glycans, and the sugars caninfluence the safety and efficacy of drugs such as erythropoietin andmonoclonal antibodies.
"When developing a drug, it is very important to understandthe roles of the sugars and have very robust technologies to quantitativelyanalyze them," says Rudd.
Spanning most areas of biology, glycobiology has allowedRudd to work on projects as diverse as prion proteins, HIV, autoimmune disease,the T-cell synapse, MHCI and immunoglobins from human and other species. Thiswork led Rudd and her colleagues to develop the tools needed for testing antibodyeffector function—tools that are crucial in the testing of future antibodiesfor efficacy and potential side effects.
Rudd's group has developed state-of-the-art glycan analysistools that can be applied to both fundamental and applied research. The robotic,96-well plate analytical platform, which allowed the first-ever correlations tobe made between the genome and the plasma glycome in a GWAS study, is alsodesigned to handle multiple samples ranging from process development to productanalysis. The hardware is linked to NIBRT software and experimental databasesto assist with data interpretation.
In this partnership, these tools and expertise will bemarried with GE Healthcare's Biacore SPR technology, a technology formonitoring molecular interactions as they occur by following changes in massconcentration close to a sensor surface.
"Biacore is a technique to understand the binding betweentwo molecules," Ljungqvist explains. "It is based on SPR and is usedsuccessfully in screening candidates in the early stages of development. Itprovides a lot of information on the same assay, and more data generated in ashorter timeframe."
The collaboration will ease some of the current challengeswith using cell-based assays, she adds: "Cell-based assays use cells as one oftheir reagents. Often it is difficult to access these cells, and they can bemore tricky to handle. You must try to make a decision on the predictedhalf-life of a drug based on an assay with high variability. They are also verytime- and labor-consuming. A much easier and quicker method is usingcharacterized reagents and biochemical assays. You get your information withless variability when well-characterized reagents are used. You can do more ofthese assays, more quickly, and generate more information earlier on."
"Increased robustness and decreased costs are appealingfeatures of any assay, and the added benefit of strong correlation withcell-based assays indicates a very strong potential for the Fc receptorplatform with industry," adds Dr. Eoin Cosgrave, a postdoctoral researcher withthe NIBRT and the lead scientist in the collaboration.
GE Healthcare and the NIBRT are investing $500,000 in thefirst year of the project, which is planned to run for two years.
GE Healthcare executes recombinant Protein L license fromAffitech
COPENHAGEN, DENMARK—GE Healthcare Life Sciences alsoannounced last month an exclusive license for the worldwide marketing and salesof products containing recombinant Protein L, granted by Affitech in a patentand know-how license agreement.
Under the terms of the agreement, GE Healthcare will payAffitech a royalty of the net sales of all related products sold by GEHealthcare.
Martin Welschof, managing director of Affitech said in apress release that Protein L has proved to be the only naturally occurringaffinity protein useful for working with both non-protein A binding antibodiesand antibody fragments.
"This is an important step forward for GE Healthcare LifeSciences and will enable us to develop new technologies to help solve some ofthe most difficult challenges faced by our customers in biopharmaceuticalmanufacturing and in protein science research," added Catarina Flyborg, generalmanager of BioProcess products at GE Healthcare Life Sciences.