Factor VIII manufactured from plasma—the ups and downs, and the up again: a personal journey—part 1: history of the development of plasma-derived factor VIII therapies
The history of the treatment of haemophilia is a success story. Despite the setbacks posed by the viral transmission epidemics, by the mid-1980s the safety of products from blood-borne pathogens was all but assured. Scientific understanding of the way in which factor VIII (FVIII) behaves in different separation processes led to the development of increasingly pure and potent preparations from plasma. In the late 1980s, the first products from recombinant technology unleashed a 13-year-old flood of technological innovation leading to the current generation of molecularly modified improved products. The capacity to produce FVIII independently from the blood and plasma donation system has also led to the potential of unlimited supply and the attainment of treatment for all the global population of people with haemophilia. Despite these developments, FVIII concentrates derived from human plasma continue to represent an important sector of the market, with a relatively strong presence in the emerging economies. Recent studies indicate that some plasma-derived FVIII (pd-FVIII), at least those containing von Willebrand factor, may offer some therapeutic advantages relative to recombinant products, particularly in the area of FVIII inhibitors. In this, first part, of my personal journey in FVIII, I will review the history of this product.