Belgian firm will now perform release-testing on drug substance and drug product batches
Belgian biopharmceutical firm Ablynx 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, which was inspected in November 2011.
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, chief executive of Ablynx, said the GMP certification is a testament to the firm’s commitment consistently to perform at a high standard in its internal and partnered development programmes.
‘This is an important step forward as we continue to transform into a product-based company,’ he added.
Ablynx currently has more than 25 programmes in its pipeline and seven nanobodies in clinical development. The firm has ongoing research collaborations and partnerships with Boehringer Ingelheim, Merck Serono and Novartis.