rFVIII is a replacement protein used for the treatment of hemophilia A and is produced by cells which have been genetically modified to produce and secrete the desired active ingredient.
At present, Bayer manufactures its approved rFVIII product Kogenate at its facility in Berkeley, California but with plasma protein-free and long-acting rFVIII products in Phase III trials, the firm pledged yesterday to invest over €500m in additional manufacturing capacity at its Wuppertal and Leverkusen, Germany facilities.
“More and more people with hemophilia are gaining access to modern treatments and improved administration regimes,” Bayer spokesperson Gisela Lenz told Biopharma-Reporter.com, adding “the increase in availability to previously undersupplied patient groups, particularly in economically emerging regions, is also contributing to growth.”
Furthermore, there is a “change from ‘on-demand’ treatments,” for example patients needing the drug at the time of a bleeding event, to “long-term prophylactic treatment, (patients maintain levels of rFVIII in their blood by 2-3 times/week infusions and so can lead a normal life)” which is fuelling a higher demand for haemophilia drugs.
The investment, which will add around 500 new jobs at the two plants, includes new buildings – for manufacturing, warehousing, laboratories, sterile filling and packaging – as well as new equipment, Lenz added.
Bayer is not the only firm to manufacture rFVIII products, and though Lenz would not tell us how its products differed in manufacture to others, the firm is investigating an updated version of Kogenate which is produced without the addition of any components of animal or human origin.
Swedish firm Octapharma makes its (not yet approved) haemophilia treatment using HEK cells in stainless steel bioreactors, whilst Pfizer’s rFVIII drug is made from CHO cells.
Last year, Octapharma invited Biopharma-Reporter.com to visit its facility in Stockholm and told us the use of human cells “eliminates the immunogenicity problems associated with products already on the market.