PFP has developed a patent protected cell line that is high yielding for a standard half-life rhFVIII through codon-optimisation of the FVIII DNA sequence. PFP also developed, together with CRO partner Ingenza, a proprietary bioproduction process. This cell line, combined with the optimized production process, delivers significantly higher yields than the industry standard, enabling to manufacture a recombinant FVIII at a much lower cost of goods.
With the independent services of the Universities of Dundee and Surrey, PFP has characterised its standard half-life rhFVIII showing it to be indistinguishable in structure and activity from a currently marketed comparator.
PFP’s second lead asset is based on its codon-optimised standard half-life rhFVIII but includes some innovative modifications in the DNA sequence for FVIII to enhance the FVIII half-life significantly. PFP is currently testing this novel approach to an enhanced half-life FVIII in a preclinical Proof-of-Concept study.
It is expected that the same proprietary manufacturing process can be applied to this enhanced half-life rhFVIII, allowing to manufacture it at a low cost as well.