Therapeutic Drug Monitoring ELISA Kits

The ELISA Genie Therapeutic Antibody, Biosimilar & Anti-Drug Antibody (ADA) ELISA kits are a premium range of kits designed to detect free therapeutic antibodies, biosimilars and Anti-Drug Antibodies in serum & plasma samples. ELISA Genie Therapeutic Drug Monitoring ELISA Kits provide quantitative ELISA kits for the measurement of the World’s leading therapeutic antibodies & biosimilars.

These kits use the highest quality components and are manufactured under ISO 13485 quality systems.

Our range of ELISA kits have many applications, for example in therapeutic drug (antibody) monitoring (TDM). TDM is the clinical practice of measuring specific drugs at designated intervals in order to maintain a constant concentration in a patient's bloodstream, thereby optimizing individual dosage regimens.

TDM kits allow clinicians to adjust therapeutic antibody dose according to the individual pharmacokinetic characteristics of each patient. The optimal therapeutic concentration can therefore be achieved more rapidly while minimizing drug toxicity. Additionally, TDM can help to identify problems with medication compliance among non-compliant patient cases.

As with almost all biologics, therapeutic antibodies can produce an immune response which leads to the production of anti-drug antibodies (ADA). Most ADA responses to therapeutic monoclonal antibodies (mAbs) are directed against the antigen-binding site of the biologic, and hence are neutralizing. This anti-drug antibody response explains why even fully human antibodies can still be highly immunogenic.

Anti-drug antibodies cause undesired immunogenicity, which can reduce the therapeutic effects of the biologic treatment. ADAs can also result in unwanted adverse effects in some cases. Detecting and monitoring the level of anti-drug antibodies can be of high importance when assessing adverse drug reactions. ELISA Genie provides a range of immunogenicity assays for anti-drug antibody (ADA) analysis.

A biosimilar is a biologic product with highly similar quality, safety and efficacy characteristics to an already approved biotechnological product (reference product). There are no clinically meaningful differences between the biosimilar and the reference biologic in terms of these product standards. Today, as data exclusivity periods of first wave biologics approach expiration/have expired, several biosimilar products are being developed or have already been approved for human use.

Like all biologics, biosimilars are structurally complex proteins that are typically manufactured using genetically engineered animal, bacterial or plant cell culture systems. As a consequence of this molecular complexity and the proprietary nature of the manufacturing process, which will inevitably result in the use of different host cell lines and expression systems as well as related differences in manufacturing conditions, it is not possible to manufacture exact copies of a reference biologic.

ELISA Genie Biosimilar ELISA Kits are highly specific and sensitive assays, designed for the in vitro detection and quantification of therapeutic antibodies in biological samples including both serum and plasma. We offer a range of research-level biosimilar therapeutic antibodies and ELISA kits for your experimentation needs.

Check out our Ebook which provides and overview of the top 10 biologics and key information regarding their application, mode of action and biosimilars.

The detection step in an ELISA is last step to measure the amount of analyte that you have in your sample. The signal generated during the detection step is proportional to the amount of analyte bound.

Chromogenic is the most popular and most widely used technique for ELISA detection and involves the horse radish peroxidase (HRP) substrate TMB (3, 3’, 5, 5’-tetramethylbenzidine) which yields a blue colour when oxidized and turns to yellow following the addition of sulphuric acid. Which allows samples to be read at 450nm on an ELISA plate reader.

Calculating the results using the following equation:

The relative O.D.450 = (the O.D.450 of each well) – (the O.D.450 of Zero well)

The standard curve can be plotted as the relative O.D.450 of each standard solution (Y) vs. the respective concentration of the standard solution (X). The concentration of the samples can be determined from the standard curve. It is recommended to use professional software such as curve expert 1.3.

The kit is shipped at ambient temperature (10-30°C) and should be stored at 2-8°C for long term storage. Keep away from heat or direct sunlight.

For more ELISA troubleshooting tips click here

Reagents are poorly mixed, the standard has degraded or pipetting errors.