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news.Ablynx, a pharmaceutical company focused on developing nanobodies, has received an extended certificate of good manufacturing practice (cGMP) from the Federal Agency for Medicines and Health Products (FAMHP) in Belgium for its new GMP unit at its headquarters in Ghent.
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The certificate was granted following inspection of the facility in November 2011.
Ablynx’s GMP unit will now perform release-testing on Drug Substance and Drug Product batches besides independently performing all stability studies on these batches.
According to the company, the large scale GMP manufacturing of nanobodies will continue to be outsourced to contract manufacturing organisations (CMO).
Ablynx CEO and chairman Edwin Moses said the GMP certification reflects their commitment to consistently perform in their internal and partnered development programmes.
"This is an important step forward as we continue to transform into a product- based company," Moses added.