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

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Therapeutic Drug Monitoring (TDM)

Biopharmaceuticals, Immunogenicity and Personalized Medicine

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

TDM Test Portfolio

Explore our range of Therapeutic drug
monitoring tests

Assay Principles

Learn more about the different assay principles we use

Sampling Instructions

Learn more about  sampling  for Therapeutic Drug Monitoring of all biologicals

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.

Immunogenicity

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 & Clinical Relevance

Personalized Medicine

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

When drug levels are decreased in a non-responder, this may reflect formation of neutralizing antibodies directed to the biologic treatment. Immunogenicity testing identifies presence or absence of neutralizing antibodies, which guides the next treatment decision – switch to other biological treatment, lowering of dose or intensify dosing. Reducing drug dosage in well-responding patients with relatively high drug levels cuts down cost.  A personalized approach can improve therapy efficacy and quality of life.

Clinical Relevance

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.