BAC Affinity Ligand Licensed for Clinical and Commercial Scale-up of LFB Biotechnologies' Recombinant Factor VIIa

NAARDEN, Netherlands--(BUSINESS WIRE)--

BAC BV, the leading provider of antibody-based affinity purification technology, 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 GTCB.

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.

About BAC
BAC BV offers a wide range of products and services for affinity purification of biological materials from complex media. The Company’s proprietary CaptureSelect^® affinity ligands, based on Camelid single chain antibody fragments, have been proven to be suitable in a wide range of biological applications including Life Science Research and Biomanufacturing. BAC’s CaptureSelect ligands are available through the Company’s custom design service, or as off-the-shelf bioprocess products through commercial partners. CaptureSelect ligands for research applications are available direct from BAC through the Company’s web shop.

CaptureSelect^® ligand technology is based on selection of single chain antibody fragments with desirable chromatographic characteristics including robustness, high specificity and flexibility. Suitable ligands are cloned and expressed in high-titres through an animal-free Saccharomyces cerevisiae-based process.

BAC BV was established in 1995 as a Unilever subsidiary. Currently the Company employs 37 people with an R&D laboratory facility in Leiden and a state-of-the-art ISO 9001 certified manufacturing plant in Naarden, the Netherlands. For more information about BAC, visit our website at www.bac.nl. For more information about CaptureSelect^® products, visit our website at www.captureselect.com

About LFB Group
LFB Biotechnologies (a French société par actions simplifiée) is both a strategic shareholder in GTC and the strategic partner of GTC in their joint venture called LFB/GTC LLC. LFB is a biopharmaceutical group that develops, manufactures and markets medicinal products for the treatment of serious and often rare diseases in several major therapeutic fields, namely Hemostasis, Immunology and Intensive Care. The LFB Group is the leading manufacturer of plasma-derived medicinal products in France and 6th worldwide and is also among the leading European companies for the development of monoclonal antibodies and new-generation proteins based on biotechnologies. With its strong focus on research, the LFB Group is pursuing a growth strategy that seeks to extend its activities at the international level and develop innovative therapies. In 2008, the LFB Group reported total turnover of 352,4 million euros, an increase of 9%, and invested 66,6 million euros in product development. The LFB Group markets its products in 20 countries around the world.