Anti-Drug Antibody (ADA/NADA)
Agro-Bio develops specific, ready-to-use, and characterized anti-drug antibodies (ADA) and neutralizing anti-drug antibodies (NADA). These anti-drug antibodies serve as a positive control for assessing the immunogenicity of biotherapeutic products (therapeutic antibodies, bispecific antibodies, biosimilars, proteins, etc.).
Anti-drug antibodies for your immunogenicity testing
Administration of biopharmaceuticals can induce an immune response in some patients. This response leads to the production of circulating anti-drug antibodies (ADAs), which may be neutralizing (NADAs). The presence of these ADAs or NADAs results in a loss of therapeutic efficacy.
To assess this immunogenicity, regulatory agencies such as the EMA (European Medicines Agency) recommend the use of positive controls with anti-drug polyclonal antibodies—which best represent an immune response—or with anti-drug monoclonal antibodies.
The production of drug-specific antibodies
Agro-Bio develops these critical reagents quickly. We offer characterization and validation services to enable these reagents to be retested at regular intervals.
Our polyclonal protocol consists of 4 steps.
Immunization
Specific purification process tailored to each project based on the drug candidate and the method used to detect these ADAs
Characterization of ADAs and NADAs
Safety assessment and periodic retesting
Our protocol is suitable for all types of biologic therapies: therapeutic antibodies, bispecific antibodies, biosimilars, recombinant proteins, etc.
It is particularly well-suited for generating initial reagents at a lower cost and in a shorter timeframe.
→ Agro-Bio also offers the development of custom murine monoclonal antibodies.
Learn more about our multi-step approach to monoclonal antibody development
Agro-Bio, your partner in ADA (anti-drug antibody) and NADA (neutralizing anti-drug antibody) development
We develop specific polyclonal ADA (anti-drug antibodies) and NADA (neutralizing anti-drug antibodies) to meet the requirements of your immunogenicity studies.
You want to discuss your anti-drug antibody (ADA) or neutralizing anti-drug antibody (NADA) project?
Regulatory reference:
According to the EMA’s CHMP (Committee for Medicinal Products for Human Use):
“Ideally, an antibody positive control should be a human preparation [...]. However, sufficient human serum is often not available to serve as a positive control preparation. In such cases, […] animal serum raised against the product as a reference can be used.”
(Excerpt from the guideline: Guideline on Immunogenicity Assessment of Therapeutic Proteins, EMA/CHMP/BMWP/14327/2006 Rev. 1, May 18, 2017.)