prepare for the unwanted

Predicting adverse effects
before they happen


Monitoring adverse effects in the Complement System

The complement system has moved into the focus of drug development efforts in the past decades, as its inappropriate and uncontrolled activation has been recognized in many diseases.

As an  important part of our innate immune response, the complement system is the first line of defense and it protects us from various infections and pathogenic threats. As Complement activates in an exponential way due to an internal amplification loop, this volatile and rapid-acting system has the potential to do great harm if not tightly regulated. Over-activation can lead to various diseases or make us susceptible to infection.

The role of Complement in drug development

It is becoming  increasingly clear that an understanding of the complement system in relation to disease mechanism, and matching of drug modality and mode of action to the right disease and patient population is critical for drug development success.

Many pharma companies are working on drugs for manipulating complement activity via specific activation pathways, or isolated complement components but it is also important to keep in mind that different drugs can cause adverse effects based on how they unintendedly interact with single components or segments of the complement pathway, and how this in turn affects the rest of the complement system. Adverse effects related to the complement system can occur in response to various biomaterials or therapeutic cells.

The complement system can also be activated by artificial surfaces, for example during hemodialysis or cardiopulmonary bypass, resulting in increased levels of TCC. TCC is therefore well suited for studies of complement activation by biomaterials in medical devices and part of the recommended tests for assessing complement activation according to ISO standard 10993-4 for hemocompatibility testing.

Assessing Complement - critical for drug development success

Preventing adverse reactions
Provide safer treatment

Each year, many patients are affected by adverse reactions that might be due to complement activation. These reactions are critical and the most severe cases can lead to hospitalization or even death.

Assessing the risk of unwanted Complement activation is often recommended to predict possible adverse reactions from medical devices, such as grafts, stents, hemodialysis and cardiopulmonary bypass, but also to biological drugs and nanomedicines.

Complement activity biomarkers can be used successfully to investigate and rule out if a drug is toxic or if a reaction is due to other related issues such as “infusion reactions” or more specifically complement activation-related pseudoallergy (CARPA). Infusion reactions has been reported to several pharmaceuticals such as biologicals and nanomedicines.



Svar has over 15 years’ experience of complement system assay development. Our complement system assays have been developed by our experienced scientists in close collaboration with key opinion leaders, to yield sensitive, reliable and easy-to-use products for the exploration of most aspects of the complement system.

Svar offers Complement assays to explore every angle of complement system-involvement in a wide range of application areas:

Bioanalytical Services

  • Validation of drug targets and batch release
  • Evaluation of off-target reactions
  • Development of treatment algorithms and monitoring regimens


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