Galapagos NV: business update: http://t.co/6w1jppWE
posted 3 days ago
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Ablynx [Euronext Brussels: ABLX] today 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."
Good Manufacturing Practice (GMP) is that part of a Quality Management System which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use.
The Federal Agency for Medicines and Health Products (FAMHP) is the competent authority responsible for the quality, safety and efficacy of medicines and health products in Belgium.
Ablynx is a biopharmaceutical company engaged in 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, including inflammation, haematology, oncology and pulmonary disease. Today, the Company has over 25 programmes in the pipeline and seven Nanobodies in clinical development. Ablynx has ongoing research collaborations and significant partnerships with major pharmaceutical companies, including Boehringer Ingelheim, Merck Serono, Novartis, and has had a collaboration with Pfizer. The Company is headquartered in Ghent, Belgium and currently employs over 290 people.
Source: Ablynx
Tags: research
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