Do you use a recombinant factor product? Do you know how it’s made?
Recombinant products are not produced from human blood plasma. They are produced in large stainless steel tanks, called bioreactors, which contain trillions of cells. Into each of these cells, a gene for human factor has been inserted, or “recombined”—the origin of the name recombinant. These genes produce human factor and release it into the culture medium—a nutritious liquid that keeps the animal (or host) cells alive and growing. Although the source material is not blood, some recombinant products contain extraneous human or animal proteins introduced during the production process or added to the final product.
To distinguish between the various production processes, recombinant products are classified according to generation. Generation refers not only to when the products were first developed and commercially available, but also to the presence of animal or human proteins used in the production process or the final product.
First-generation recombinant products, introduced in 1992, use human or animal proteins in the growth medium. These products also contain human albumin added at the final production stage to help stabilize and bulk up the product.
Second-generation recombinant products contain no human albumin added to the final product, but do use human or animal proteins in the growth medium.
Third-generation recombinant products, first available in 2003, contain no human or animal proteins in the growth medium or added to the final product. They have the lowest risk of transmitting viruses.
And while MASAC (NHF’s Medical and Scientific Committee) has not yet confirmed the nomenclature of fourth generation, Octapharma and Sanofi Genzyme each created a recombinant factor product that is created from a human cell line, not animal. The two companies are calling their products, Nuwiq® (Octapharma) and Eloctate (Sanofi Genzyme) fourth generation.
If you are using recombinant product, what generation is your factor? Download our Factor Comparison Chart and find out!