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01-13-2012: Ablynx announced that it has been granted an extended Certificate of Good Manufacturing Practice (GMP) from the Federal Agency for Medicines and Health Products (FAMHP) in Belgium for its new GMP unit at its headquarters in Ghent, after having been inspected in November 2011.
Having received this accreditation, Ablynx's GMP unit will now perform release-testing on Drug Substance and Drug Product batches and independently perform all stability studies on these batches. The large scale GMP manufacturing of Nanobodies® will continue to be outsourced to contract manufacturing organisations (CMO).
Dr Edwin Moses, CEO and Chairman of Ablynx, commented: "GMP certification of our laboratories in Ghent is a testament to Ablynx's commitment to consistently perform at a high standard in our internal and partnered development programmes. This is an important step forward as we continue to transform into a product-based company."
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Founded in 2001 in Ghent, Belgium, Ablynx is a biopharmaceutical company focused on the discovery and development of Nanobodies®, a novel class of therapeutic proteins based on single-domain antibody fragments, for a range of serious and life-threatening human diseases. The Company currentl ... more
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