Ingenza has reached an important milestone in its work to develop a low cost recombinant human factor VIII (rhFVIII) production process to make materials for ProFactor Pharma Ltd (PFP). The goal of this work is to enable PFP to transform the treatment of haemophilia A by offering an affordable therapeutic product suitable for markets currently excluded by the high cost of donor-derived FVIII.
Ingenza has used its synthetic biology and fermentation expertise to optimise upstream and downstream processes for the production of rhFVIII, exceeding target production goal by more than tenfold. Ingenza is now working to finalise the rhFVIII manufacturing process and generate material for PFP’s pre-clinical toxicology studies later in 2020, ahead of clinical trials in 2021.
Ian Fotheringham, Ingenza MD, commented: “This continued advancement illustrates the enormous global impact possible from strategic SME relationships within the Scottish and UK biotech communities, and we look forward to enabling PFP to fully realise the potential of low cost rhFVIII to improve the treatment of haemophilia A globally.”
Jaymin Amin, CEO of PFP, added: “The global market for rhFVIII is vast, but current supplies only reach a third of those who need it. Ingenza’s manufacturing process will ultimately deliver rhFVIII that is indistinguishable from a market-leading product and, thanks to the high yielding process and low production costs, we are in an extremely strong position to provide access to treatment in the massively undersupplied markets.”