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Recombinant treatments
Recombinant factors are simply man-made factors that are practically replicas of the factor produced naturally by the body, rather than factors that are extracted directly from human blood. They are available for both the treatment of haemophilia A (replacement of factor VIII) and haemophilia B (replacement of factor IX).
A special section of DNA is opened by an enzyme and a copy of the gene for factor VIII or IX is inserted into the DNA which is then closed back up.
There are three types of recombinant factor and the differences are related to how they are manufactured.
Generation one recombinant factors
(also known as first generation)
Generation one recombinant factors are manufactured using cell banks rather than donated plasma, however all these products contained pasteurised human albumin in the production process as a stabiliser added to the final product.
These concentrates were demonstrated to be as effective as plasma-derived therapies, and had the advantage of exposing patients to significantly reduced risk of pathogen infection.
Generation two recombinant factors
(also known as second generation)
Generation two was the next major development in clotting factor technology through the removal of albumin as a stabiliser in the final product.
There was a perception among patients and clinicians that although albumin had not been shown to transmit pathogens there was still a risk associated with its use.
Generation two recombinant products use sucrose or other chemicals to replace albumin in the final formulation.
Generation three recombinant factors
(also known as third generation)
Generation three recombinant products are the latest development in clotting factor technology.
These products do not use human or animal proteins at any stage of manufacture.
