PFP has developed a patent protected way to make recombinant Factor VIII in a bioprocess delivering significantly higher yields than the industry standard, giving us a much lower cost of goods.
We have been able to achieve this superior yield with lower cost of goods by combining a proprietary high expressing cell line (Patent Applied for – granted in Europe) with innovative single use disposable manufacturing technology. Modern downstream purification technologies (Patent Applied for) are also more efficient leading to a high yield of final product.
Based on the expression data, our manufacturing model suggests a single 100L Single Use fermenter could produce 150 million International Units of rhFVIII per year. And this process is eminently scalable. A 1,000L fermenter could produce 1.5 billion IUs. This would serve to increase the current world production of almost 9BN IUs.
With the independent services of the Universities of Dundee and Surrey, PFP has characterised its rhFVIII showing that it is indistinguishable from a currently marketed comparator.