Immunogenicity

Immunogenicity is a measure of the immune response to a therapeutic drug . It is a very relevant problem affecting the use of therapeutic protein drugs. The development of anti-drug antibodies (ADAs) can cause allergic or anaphylactic reactions, reduction in efficacy, and/or induction of autoimmunity. Both manufacturers and regulatory authorities are focusing on immunogenicity testing, which becomes an integral part of protein drug development, to determine whether patient may produce antibodies to biologics and assess their consequences.

Immunogenicity testing proceeds in three major steps i) screening assays ii) confirmatory assays and iii) neutralising assays

We have experience in developing assays and writing GLP procedures acceptable to regulatory agencies. We are well equipped to test your drug candidates in animal models (from mouse to non-human primate) to human samples issued from clinical trials.

Our services include:

Screening assays

• Production of appropriate positive control antiserum
• Purification of reference standard
• Characterization of immune response in serum samples, providing information on isotype, specificity, kinetic profiles and affinity using Bioacore system
• Antibody isotyping
• Development and fully validated assay of bridging or ELISA, RIA assays including Mesoscale ECL detection

Confirmatory assays

These tests are generally performed using the same format as screening assays. immunodepletion/competition assays are employed to confirm results of neutralizing assays. In these validated assays, antibodies are specifically removed or competed from patient samples and the loss of response is determined.  

Neutralising assay

Bertin Pharma has a wide range of tools, either robust or advanced technology, to see whether the ADAs may binds to the biologics in a way that can block the effectiveness of the drug. Depending on the biological activity of the drug a functional assay is developed to assess the neutralizing activity of ADAs. We have experience in the following assays:

• Cell-based neutralising assays
• Enzyme based neutralising assays

Routine analysis in GLP

Preclinical or clinical study samples will be analyzed and results reported according to GLP guidelines using the validated methods. Samples that have been shown to have ADAs will be further titrated to quasi-quantitate the amount of binding and neutralizing ADAs in the samples.

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Related services
- Protein & HCP analysis
- Immunomonitoring