BAC and Octapharma Extend Recombinant Factor IX Collaboration
News Nov 04, 2009
BAC BV has announced that it has entered into a licence agreement with Octapharma to use BAC’s anti-Factor IX CaptureSelect® affinity ligand in the large scale purification of recombinant Factor IX (FIX). Octapharma produces FIX for the treatment of bleeding in Haemophilia B.
The licence agreement follows on from successful completion of feasibility studies. Concurrently, the companies have embarked on a new discovery programme under which BAC will develop a CaptureSelect affinity ligand for the purification of recombinant human granulocyte-colony stimulating factor (G-CSF), which has applications in oncology and haematology.
Under the terms of the FIX agreement Octapharma will have licence to use BAC’s anti-FIX for the purification of FIX from mammalian cell culture. Under the terms of the G-CSF agreement BAC will perform ligand discovery and development to provide an anti-G-CSF ligand, which will then undergo feasibility studies at Octapharma.
Factor IX is an essential product for the prophylaxis and treatment of bleeding in Haemophilia B, an X-linked recessive blood disorder that affects around 1 in 30,000 men. Octapharma currently markets a plasma-derived FIX product and is now progressing its recombinant FIX project. G-CSF is a hormone that stimulates bone marrow to produce white blood cells and stem cells, and has therapeutic uses in oncology and haematology.
“The progression of the Factor IX programme from feasibility study to scale up, and the initiation of the G-CSF project, are significant in our ongoing relationship with Octapharma,” said Dr Laurens Sierkstra, CEO of BAC. “All the team here at BAC are delighted that our anti-FIX ligand has proven to be such a good fit for Octapharma’s downstream processes, and we are looking forward to working on its scale-up and developing a new affinity ligand for G-CSF.
“It is important for Octapharma to have access to a technology for the development of affinity resins that are completely free of animal-derived components,” said Kim Bjornstrup, Vice Chairman of Octapharma Group. “This is important for us to be able to fulfil our continuous intentions to provide a safe product portfolio. The BAC affinity ligand concept has fulfilled this need, and in addition has been a powerful tool in the purification process, facilitating a final product of highest purity.”
Octapharma is currently performing clinical trials with a proprietary recombinant Factor VIII product produced in a human cell line (HEK293F cells) intended for the treatment of Haemophilia A patients. The purification of this product also includes an affinity ligand developed by BAC and supplied by GE Healthcare (VIIISelect affinity resin).
BAC’s CaptureSelect 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-FIX ligand as a resin suitable for commercial-scale bioprocessing. Octapharma will have full access to GE Healthcare’s experience and support in fulfilling regulatory requirements during scale-up and ongoing production.
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