What You Should Know About Immunogenicity Testing of Biological Drugs

Recombinant monoclonal antibodies (rMAbs) are becoming more frequently used as drugs to treat immune diseases and different types of cancer. These types of drugs are more safely degraded by the human body than traditional small molecule drugs. Small molecule drugs may cause adverse effects as they are metabolized and possibly produce toxic products. Biological drugs, most commonly in the form of antibodies, can be less prone to producing an immune response than small molecule drugs because they are replacing a naturally occurring protein. Small molecules are often treated by the immune system as a threat, and the body may launch an attack on these “invaders.” Therapeutic proteins (rMAbs), if they don’t mimic the naturally occurring protein, can also produce an immune response, with the body seeing it as an “invader.” During drug development, regulatory agencies require pharmaceutical companies to test biological drugs so that they are safe for patients.

Researchers in the UK have developed a test to monitor for an immunogenic response during clinical trials and it can detect different types of anti-drug antibodies in a single sample. The advantages of this test are:

  • It can simultaneously detect between specific and non-specific drug antibodies.
  • It is sensitive and robust.
  • It requires only a small volume of serum or plasma.
  • It reduces the number of animals used in pre-clinical trials.

Researchers at Astra Zeneca and the University of Gothenburg have developed a single test that can simultaneously determine anti-drug antibody class and subclass as well.

What do you think about using this assay format compared to your current immunogenicity method?