June 2008

 

ibpn international blood/plasma news

Swedish scientists at OCTAPHARMA AB report that they have developed a B-domain deleted recombinant factor VIII that can be expressed in a human cell line. Use of the human embryonic kidney cell line HEK293 in lieu of current small rodent cell lines is expected to produce a factor VIII molecule with a human glycosylation pattern, potentially resulting in improved function and reduced product immunogenicity.

The method of production uses a gene construct for a B-domain deleted factor VIII protein and stable clone cell developed at Munich-based Octapharma Biopharmaceuticals GmbH. The product harvested from cell culture in a serum-free medium is purified by five chromatography steps, and includes solvent detergent treatment and nanofiltration steps to inactivate and remove viruses, respectively. The final product has a factor VIII specific activity in excess of 9,000 IU/mg protein. In a direct comparison, this factor VIII protein demonstrated 40 % higher von Willebrand factor binding affinity than murine-based recombinant factor VIII products.