Therapeutic Drug Monitoring

Therapeutic drug monitoring (TDM) is a branch of clinical chemistry and clinical pharmacology that specializes in the measurement of medication concentrations in blood. TDM aims to improve patient care by adjusting the dose of medication for which clinical experience or clinical trials have shown improved outcomes in general or special populations. TDM can also help explain unwanted effects.

- Revolutionizing therapeutic intervention

The discovery and availability of biopharmaceuticals has revolutionized therapeutic intervention for many different diseases. As biopharmaceuticals consist of proteins and monoclonal antibodies that can have many targets, it has made them an invaluable addition to the treatment of various diseases. They come in a wide range of forms, from vaccines to gene therapies and over the last few years the new biopharmaceutical therapies have expanded exponentially both in range and functionality, and their development continues to grow.

Improve therapy efficacy and quality of life

When drug levels are decreased in a non-responder, this may reflect formation of neutralizing antibodies directed to the biologic treatment. Immunogenicity testing is used to identify presence or absence of neutralizing antibodies, which guides the next treatment decision – switching to other biological treatment, lowering of dose or intensify dosing. From a health economic perspective, the possibility to reduce drug dosage in well-responding patients with relatively high drug levels enables a more cost effective approach.  


Clinical Relevance

Improve efficacy of therapy 

With drug level testing of biologics, efficacy of therapy can be improved if biological levels are tested, as treatment decisions may need to be adapted depending on the test results in conjunction with clinical responses to treatment. 

After developing neutralizing anti-drug antibodies (NAbs), the treatment effect may be greatly effected and consideration should be given to switching to another treatment.


Immunogenicity is the ability of therapeutic proteins to provoke an antibody response targeting themselves, since they contain unique sequences that can elicit an immune response. Clinical trials with Remicade (infliximab) showed that 10-51 % of treated patients developed anti-drug antibodies (ADA) against Remicade (Vincent 2013).

The anti-Remicade antibodies were analyzed by an ELISA method which measures binding ADA, and cannot determine whether these factors have functional significance, i.e. if the ADA neutralizes the effect of the drug.

Depending on how the methods are built, there is a risk of false negative and false positive results.

Today, authorities require estimations of immunogenicity in the clinical trial programs (Phase I through Phase IV) for new biological drugs (EMA 2007 and 2012 and the FDA draft 2009). According to EMA and FDA, tests for neutralizing anti-drug antibodies (NAbs) with a biological activity assay should be included where it is relevant.

Personalized Medicine

Monitoring biologic levels in individual patients allows optimization of treatment efficacy by adjusting therapy depending on the specific response of the patient. To consider therapeutic drug monitoring is of vital importance for all patients treated with biologics, as it contributes to making accurate and patient-specific treatment decisions. 


Benefit from an individualized treatment approach to TNF-alpha therapy

TNF-α inhibitors are excellent tools for treatment of severe chronic inflammatory diseases and many patients benefit from an individualized treatment approach depending on their response to the biological drug. Learn more about how to measure the biological activity of TNF-α inhibitors.

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Limitations of biopharmaceuticals

Besides the huge benefits that come with the use of biologics, there is one major limitation that arises when using these therapeutics: anti-drug antibodies (ADAs)

Since biologics are proteins, they can be recognized by the immune system as foreign molecules, and so the body can mount an immune response against them in the form of ADAs. Some ADAs neutralize the biological drugs and decrease the drug’s efficacy and increase its clearance, resulting in patient secondary unresponsiveness, leading to worsening of their disease. 

Measure of drug level and immunogenicity

Although these new biologic therapies have now been prescribed to many patients, there remains a lack of routine clinical assessment of the drug levels and immunogenicity in serum. We provide an accessible way of assessing drug efficacy and immunogenicity.


Drug Level 




Orencia® (abatacept)

Humira®, Amgevita, Imraldi, Hyrimoz, Hulio (adalimumab)


Cimzia (certolizumabpegol)

Soliris® (eculizumab)

Erytropoietin (EPO)


Simponi (golimumab)

Remicade®, Inflektra™, Remsima™ (infliximab)


Tysabri® (natalizumab)



Mabthera®, Ritemvia, Rixathon (rituximab)




Roactemra® (tocilizumab)




Stelara® (ustekinumab)




Entyvio® (vedolizumab)





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