The treatment of patients that develop an immune response is more complex, less effective and exceedingly expensive. Unfortunately, the development of anti-drug antibodies against the infused FVIII is a significant impediment to this strategy. Although there is no cure for hemophilia A, infusion of the FVIII therapeutic protein has been one of the most successful examples of management of a chronic disease. The problem of defective FVIII is genetically based. People who do not have sufficient quantities of FVIII, or whose FVIII is defective in some way, suffer from hemophilia A, a disease in which blood clotting is defective and leads to excessive bleeding. A T-cell response mismatch like this sometimes occurs in the case of the protein FVIII, a protein that is critical to the body's ability to form blood clots to stop bleeding. In that case, the T-cells respond to a normal, artificial protein therapeutic as if it were foreign, since it is different from the defective, natural protein. This happens if the natural protein made by the body is defective in some way. The immune response to protein-based therapeutics also involves T-cells, which help to activate B cells so they produce antibodies, including those that block protein therapeutics. Therefore, a critical part of determining the clinical safety and efficacy of protein-based therapeutic products is measuring their tendency to trigger antibody formation. Such antibodies can also cause complications that can be life-threatening. One form of immune response is activation of B cells, which produce antibodies that bind to the proteins and reduce or eliminate their therapeutic effects. Office / Division / Lab: OTAT / DPPT / HBĪ major problem with protein-based therapeutics is their immunogenicity, that is, their tendency to trigger an unwanted immune response against themselves.
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