Human Cell-line

Recombinant coagulation FVIII from a human cell line (Human-cl rhFVIII)

 

Formation of neutralizing FVIII-antibodies is presently the most devastating complication of FVIII replacement therapy in patients with Haemophilia A. Human-cl rhFVIII is a newly developed recombinant FVIII (rFVIII) concentrate produced in genetically modified human embryonic kidney (HEK) 293F cells.

Thus, Human-cl rhFVIII is the first rFVIII with human-like post-translational modifications (PTM) and does not contain antigenic residues (e.g. NeuGc or Gal-alpha1,3-Gal) that are present in rFVIII from non-human but hamster cell-lines like CHO or BHK.

 

Furthermore, the manufacture of Human-cl rhFVIII is free of human or animal derived added materials, including albumin, which is in line with the most recent recommendations from regulatory and physician`s organizations. Human-cl rhFVIII has successfully entered the global clinical development programme.

With the development of the HEK293F cell-line, Octapharma has the necessary resources and superior biotechnology platform in place to realize further treatment opportunities not only in our core area of Haemophilia and other bleeding disorders, but also in the broader field of Haematology.

Our “Growth through innovations” pipeline strategy will enable us to meet the needs of even more patient groups by strengthening our portfolio with new products and by expanding our product portfolio into new therapeutic areas of Haematology.

For the latter, the development of recombinant G-CSF (Granulocyte colony-stimulating factor) from the HEK293F cell-line is thus representing another key R&D project in our research activities. G-CSF is a glycoprotein hormone, which stimulates the bone marrow to produce and release granulocytes and stem cells into the circulation. Current G-CSF products are all recombinant and manufactured in E. coli or hamster (CHO) cell-lines.

Established G-CSF indications are the reduction of the duration and incidence of neutropenia and infections in patients receiving chemotherapy after bone marrow transplantation and peripheral blood progenitor cell mobilization.