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BAC Affinity Ligand Licensed for Scale-up of LFB Biotechnologies’ Recombinant Factor VIIa

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BAC BV has announced that it has extended its license agreement with LFB Biotechnologies (Les Ulis, France), to cover the use of BAC’s anti-Factor VIIa CaptureSelect® affinity ligand in the large-scale purification of recombinant human Factor VIIa (rhFVIIa).

LFB Biotechnologies, a biopharmaceutical company working in the highly specialized field of plasma-derived medicinal and biotech products, began working with BAC in May 2008 to develop a custom-designed affinity ligand for the purification of the rhFVIIa product that it developed in partnership with GTC Biotherapeutics.

BAC and LFB Biotechnologies have now entered into a license agreement to use the custom ligand in larger-scale production processes. Under the terms of the agreement, LFB Biotechnologies will have license to use BAC’s anti-FVIIa CaptureSelect ligand for the purification of rhFVIIa from transgenic animals expressing the recombinant protein during lactation.

The CaptureSelect ligand has demonstrated ability to achieve high purity in downstream processing, and has the potential to enhance the cost reduction benefits of the transgenic expression system developed by LFB Biotechnologies and GTC Biotherapeutics.

Factor VIIa is an essential protein for certain blood coagulation disorders. Recombinant FVIIa is used to treat and prevent bleeding episodes in hemophilia A and B patients with inhibitors to Factor VIII or Factor IX, and in patients with acquired hemophilia. It is also increasingly being used to treat uncontrollable hemorrhages.

“Progressing from feasibility study to this scale-up stage is a critical time for both BAC and LFB Biotechnologies, which will be supported by the close and successful relationship that has developed between our two companies,” commented Laurens Sierkstra, CEO at BAC. “Although the flexible nature of the CaptureSelect platform means that we can produce a ligand for any protein product, it has been extremely interesting to work with such a novel expression system.”

“This collaboration with BAC for the development of a specific ligand for our recombinant factor VIIa is a significant step for the downstream process of this strategic project” commented Sami Chtourou, Director of technology platforms and innovation at LFB Biotechnologies.

BAC’s CaptureSelect ligand technology uses a unique type of antibody fragment to create a highly specific affinity ligand for the single-step purification of any target protein. BAC has partnered with GE Healthcare to provide the anti-FVIIa ligand as a resin suitable for commercial-scale bioprocessing. LFB Biotechnologies will have full access to GE Healthcare’s experience and support in fulfilling regulatory requirements during scale-up and ongoing production.