Omalizumab (Xolair®) is a recombinant humanised monoclonal antibody that selectively binds to human IgE, used to reduce allergic reactions.

Omalizumab is a humanised monoclonal antibody that selectively binds to human immunoglobulin E (IgE), manufactured by recombinant DNA technology in a Chinese hamster ovary cells.

Mechanism of action

Omalizumab prevents binding of IgE to FcRI (high-affinity IgE receptor), thereby reducing the amount of free IgE that is available to trigger the allergic cascade. Treatment of atopic subjects with omalizumab resulted in a marked down-regulation of FcRI receptors on basophils. 

Clinical use

In Europe, omalizumab is indicated for treatment of improve the control of severe persistent asthma that is caused by an allergy (IgE-mediated). It is used as an add-on to existing asthma treatment in patients of at least six years old.
Moreover, omalizumab is  used to treat chronic (long-term) spontaneous urticaria (itchy rash), as an add-on to existing treatment in patients aged 12 years or over who do not respond to treatment with antihistamines.

Consult CHMP for details.

What can Sanquin do for you?

We have tests that:

- can measure the levels of free drug in the serum; levels of therapeutic antibodies are assessed using validated ELISAs.

- can measure the immunogenicity of vedoluzimab; human anti-human antibodies are quantified using validated antigen-binding tests (radioimmunoassay or RIA).

As we have hands-on experience in these assays, we can provide you with accurate and reproducible test results. 

Send in samples

If you want to use our drug level or ADA testing services, email us at [email protected].