January 14, 2013 -- Procognia (Israel) Ltd, a leader in glycobiology research for over a decade, expands its analytical services activity and launches a worldwide services center for glycosylation analysis of biopharmaceuticals and biosimilars. The center, EGC - Expert Glyco-analytics Service Center, provides ICH guidelines compliant services based on various quantitative methods, including HPLC, Mass Spectrometry and GlycoscopeTM, Procognia's proprietary high throughput technology for glycosylation analysis of monoclonal antibodies.
Dr. Ruth Ben Yakar, Procognia's CEO says "Procognia's vast experience, successful track record as a service provider for global biopharmaceutical companies, and our team of experts, give EGC an unparalleled advantage in providing integrated ICH guidelines compliant solutions. EGC's experienced customer services team consists of dedicated, highly qualified biochemists and glycobiologists. Our services direct our customers towards optimal glycosylation profiles for improved efficacy and safety of their products".
The new center offers worldwide customer support through its local branches located in Germany, USA, and India, which provide customer support and handle sample shipments to EGC's analytical laboratories. EGC's analytical laboratories are located in Procognia's new cutting edge GLP facility at the Rehovot Science Park in Israel, across the street from the Weizmann Institute of Science.
About biopharmaceutical glycosylation:
Glycosylation is a significant non-template driven post-translational modification which may affect biopharmaceutical activity, stability, safety, and pharmacokinetics /dynamics. Factors such as cell-line, clone, bioreactor conditions and purification methods affect glycosylation, and may produce the same protein backbone with differences in overall structure, linkage and composition of glycans, thus affecting bioactivity, safety and efficacy of the product.
Characterization of carbohydrate structures and composition is crucial in the entire biopharmaceutical process: from clone screening, through development of the manufacturing process to in-process control.
About Procognia (Israel):
Procognia (Israel) established in 2000, is a world leader in glycobiology and biopharmaceutical analytics. Procognia offers solutions to major challenges in biopharmaceutical and biosimilar development and manufacturing, including comprehensive analytical services for achievement of optimal glycosylation profiles for improved efficacy, safety and biosimilarity. Procognia also collaborates with strategic partners for the development of high-yield biosimilar cell lines for higher productivity and lower manufacturing costs, based on proprietary molecular biology methods.