Procognia (Israel) Ltd, a leader in glycobiology research, has announced the expansion of analytical services activity and launched a worldwide services centre for glycosylation analysis of biopharmaceuticals and biosimilars.

The centre, EGC - Expert Glyco-analytics Service Centre, provides ICH guidelines compliant services based on various quantitative methods, including HPLC, Mass Spectrometry and Glycoscope, Procognia's proprietary high throughput technology for glycosylation analysis of monoclonal antibodies.

Dr Ruth Ben Yakar, Procognia's CEO said, "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 centre 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.

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.

Procognia (Israel) 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.