ProFactor Pharma Ltd (PFP) the developer of a unique, ultra high yielding cell line for the manufacture of recombinant human factor VIII (rhVIII), is pleased to announce the recent issuance of Indian Patent No. 361851 and Eurasian Patent No 529615EA.
This patent covers the way in which PFP are able to make a cell-line capable of producing what is believed to be the highest levels of recombinant Factor VIII yet developed. Expressly, the patent relates to the functional expression of recombinant factor VIII (rhFVIII) in cells and in particular to its stable expression and excretion from cells in in vitro and/or in vivo applications.
The patent has previously been issued in Europe and China.
PFP has developed a proprietary high yielding cell line which, when combined with a production process employing innovative, single use, disposable technology, can address a significant market opportunity with an affordable rhFVIII product for those markets locked out by high prices.
Haemophilia is an X-linked genetic disease associated with the dysfunction of the biological cascade leading to blood clotting. Coagulation factors are vital to the functioning of the mechanism that the human body uses to protect and repair itself from physical injury, by the formation of blood clots to seal ruptured blood vessels. Haemophilia patients have a reduced capacity to stop bleeding and are prone to bleeding internally, into joints and organs, and often require hospitalisation 3-4 times per year. Without proper treatment, haemophiliacs typically die from organ failure in their teens.
Haemophilia A is treated with replacement therapy of a human blood protein, Factor VIII which is limited in supply – by the quantity of available plasma for fractionation and by the limited installed capacity for the production of recombinant Factor VIII. The WFH estimate that more than two thirds of haemophiliacs receive inadequate or NO treatment at all.