Can we avoid TeGenero-like scenarios and be better prepared rather than waiting for dangerous and disastrous outcomes to happen in the clinical phase? We can generate more critical information on drug immune safety in the preclinical phase that could be essential in the success of the drug.
Comprehensive in vitro human Immune Testing (COMPIT) has been designed to enable preclinical in vitro testing of drugs for an in depth immunogenicity analysis – currently which is not offered by other established analytical systems. The system is based on the central dogma of immunology and the immune response against ‘Tissue Damage’. It merges cutting-edge immune response testing, 3D tissue models and ultrasensitive analytical assays. COMPIT outperforms current immune response testing and is complementary to current information obtained from preclinical studies.
Much more than just antigenicity and ADAs
Contrary to the current perception of immunogenicity of drugs, ImmunoSYS brings a disruptive method in the understanding and practice of the term. Conventionally, with the testing of ADAs the definition and perception of Immunogenicity in the drug industry is limited to the ‘antigenicity’ of a drug only. Immunogenicity is a much more complex issue. In current immunology, the ‘self and non-self’ is a redundant issue and anything that can cause an immune response is immunogenic. A drug can be immunogenic by causing tissue damage (a tissue-directed path) and providing grounds for immunity against the tissue rather than the drug. This is most likely the underlying mechanism of most drugs that cause autoimmunity and other secondary diseases. Conventional toxicology testing takes into account acute toxic damage and ignores moderate immune responses that might have pathological impact through progressive and chronic development.
This would be a concern for the drug developing party.
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