Procognia Limited Announces Receipt of cGMP Certificate for Its Glycosylation Analysis Services
9/3/2013 8:39:05 AM
August 29, 2013 -- Procognia, a biotechnology company providing analytical services to the biopharmaceutical and biosimilar industry, announced today receipt of a current Good Manufacturing Practice (cGMP) compliance certification for its glycosylation analysis services.
Procognia’s laboratories in Rehovot, Israel successfully passed a cGMP inspection held by the Israeli Ministry of Health, a member of the European PIC/s, the Pharmaceutical Co-operation Inspection organization. The inspection concluded that the services provided by Procognia comply with cGMP requirements referred to in the Conformity Assessment and Acceptance of Industrial Products (CAA) Agreement between the European Union, and the Israeli law and regulations.
Mrs. Larisa Amir, COO at Procognia says: “Our customers benefit from our high standards and quality management system. This cGMP certification, standard, ensure that Procognia’s services meet the high quality international standards required by the pharmaceutical industry”.
The cGMP compliance certificate is granted to Procognia for its biologics carbohydrate analysis services provided to biopharmaceutical and biosimilar developers and manufacturers. Procognia provides glycosylation analysis services using various methods including HPLC-based methods and Procognia’s proprietary high throughput glycosylation screening tool, the GlycoScopeTM.
Dr. Ruth Ben Yakar, Procognia’s CEO stated: “We are proud to offer our customers analytical services at the highest industry standards. This approval enables us to expand our services to in-process manufacturing control, product release, and stability testing, in addition to the services we provide for product development stages”.
Procognia (Israel), established in 2000, is a leader in glycobiology and biopharmaceutical analytics. Procognia offers services and solutions to major challenges in biopharmaceutical and biosimilar development and manufacturing, including comprehensive analytical services and access to a large database of glycosylation profiles of biosimilar references for achievement of optimal glycosylation profiles for improved efficacy, safety and biosimilarity.
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