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BAC and Octapharma
Extend Recombinant Factor IX Collaboration for Clinical and Commercial Scale
Production, and Initiate a Further Blood Disorder Programme
Naarden, The Netherlands, 2nd November 2009 – BAC BV,
the leading provider of antibody-based affinity purification technology, today
announced that it has entered into a licence agreement with Octapharma (Lachen,
Switzerland) 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 ligand 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 Björnstrup, 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.
Dr Sierkstra will be presenting further information on BAC’s commercial projects
at BIO-Europe 2009, Vienna, at 15.15 hrs on 3rd November (Shubert 2, level 1).
-Ends-
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 Octapharma
The Octapharma Group is an independent, Swiss-based biopharmaceutical company
operating worldwide. Octapharma’s core business is the development, production,
and sale of high-quality human proteins for the treatment of life-threatening
diseases.
The Group has more than 3,000 employees in 28 countries, and owns five modern,
state-of-the-art production facilities in Austria, France, Germany, Sweden and
Mexico, respectively.
Octapharma’s company mission is to provide safe and effective biopharmaceutical
products derived from human cells or blood plasma to patients in need of
lifesaving therapy.
For more information about Octapharma, visit our website at
www.octapharma.com
Media enquiries:
Kathryn Robertson, College Hill
Kathryn.Robertson@collegehill.com
Tel: +44 (0)1260 296 506
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