Biopharmaceutical Pharmacokinetic and

Immunogenicity Assessment

‘A non-profit collaborative effort of European laboratories with expertise in immunogenicity against biologics’

What is BIOPIA?

BIOPIA is a non-profit collaborative effort of European labs with expertise in biotherapeutical immunogenicity and a spin-off from the EU/IMI-project ABIRISK. The aim is to raise awareness about immunogenicity against biopharmaceutical drugs (biologics) by providing laboratory tests for drug level (therpeutic drug monitoring, TDM), including anti-drug antibodies (ADA), and thereby help clinicians assess treatment responses in their patients. We want to connect European research and routine laboratories to hospitals, clinicians and patients treated with biologics, with the goal of a having a more efficient implementation of drug levels and ADA testing in clinical routine.

The introduction of biologics and biopharmaceuticals 

  • Have revolutionised therapeutic intervention for many different diseases, from rheumatoid arthritis and multiple sclerosis to inflammatory bowel disease and cancer
  • Consist of proteins and monoclonal antibodies that can have many targets, making them an invaluable addition to the treatment of diseases
  • Over the last few years, they have expanded exponentially both in range and functionality, and their development continues to grow.

Major 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) 
  • Due to the fact that biologics are proteins, they can be recognised 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 neutralise the biologic drugs and decrease the drugs efficacy and increase its clearance, resulting in patient secondary unresponsiveness.
  • Moreover, the actual drug level in a individual patient in trough is highly variable. Both a too high level and a too low level need adjustments to keep the patient in the optimal treatment window. Therapeutic drug monitoring (TDM) using tests for drug level.  

Lack of clinical routine assessment

  • Despite our knowledge of ADA and low serum drug levels, these are not widely assessed routinely in most countires
  • This can be due to clinicians being unaware that there are tests available to monitor drug level and ADA, lack of knowledge on where these tests can be performed, and limited guidelines and recommendations on when and how to perform the tests
  • The main aim of this website is to provide a list of labs that provide tests for drug levels and ADAs for different biologics, in order for clinicians to be able to send samples for analyses