Immunogenicity is the ability of a particular substance, such as an antigen, to provoke an immune response in the body of a human or animal. Although this immune response is natural, the formation of anti-drug antibodies in a patient being treated with a protein therapeutic can have deleterious effects by neutralizing the effectiveness of the drug, altering its pharmacokinetics or, more seriously, attacking an autologous protein critical to normal physiologic functioning. As a result of this phenomenon regulatory agencies require immunogenicity screening for all protein drugs being submitted for regulatory approval.
What HBS Does For You
Haemtech Biopharma Services can develop and validate assays to detect anti-drug antibodies in patient samples to evaluate the immunogenicity of your therapeutic protein. We can develop and manufacture the appropriate control or reference material for these assays, and implement the assays by testing your samples in-house at our cGMP-certified testing facility. Examples of assays developed and implemented include anti-CHO host cell protein, anti-thrombin, anti-fibrinogen and anti-factor V.