We help physicians monitor drug levels during treatment and for diagnostic purposes

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TDM Assays Principles

iLite® Cell-Based Assays

iLite® Cell-based Reporter Gene Assay Technology is a functional method that can detect if antibodies in the patient's serum have an ability to inhibit the drug's effect, i.e. if the patient has developed neutralizing antibodies (Nabs) or not.

It is not evident from the respective drug documentation if this was considered when testing for immunogenicity during the clinical trials of the various biopharmaceuticals.

ELISA (Enzyme-linked Immunosorbent Assay)

ELISA, Enzyme Linked Immunosorbent Assay is an immunochemical measurement method where antibodies or antigens that are measured have been labeled with enzymes. The presence of antigen or antibody is detected by the ability of the enzymes to e.g. induce a color change in the test.

The assay format combine the specificity of antibodies with the sensitivity of simple enzyme assays, by using antibodies or antigens coupled to an easily-assayed enzyme. ELISAs can provide a useful measurement of antigen or antibody concentration. 

RIA, Radioimmunoassays

RIA, Radioimmunological analysis is an analytical technique used for substance determination. In the method, radioactive substance is added to the sample where this substance is to be measured. Antibodies to the substance are added and bind both labeled and unlabeled. The competition between these makes it possible to calculate how much unlabeled substance is present in the sample.