Ablynx is granted extended GMP certificate
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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