What Role does Immunogenicity Assays play in Biologic Drug Development?

Immunogenicity assays help to measure the possible immune responses of biosimilars and biologics. Biologics like antibodies and peptides can trigger an anti-drug antibody (ADA) response.

What Role does Immunogenicity Assays play in Biologic Drug Development?

Immunogenicity assays help to measure the possible immune responses of biosimilars and biologics. Biologics like antibodies and peptides can trigger an anti-drug antibody (ADA) response. Such ADA responses can result in allergic reactions, efficacy reduction, or autoimmunity induction. ADA’s neutralizing faction or Neutralizing Antibodies (Nab) might slow down the therapeutic activity. It might also endanger patient safety.

There are several possibilities of negative responses. That makes immunogenicity testing an important component of the process of drug development. FDA has mandated assay development to be carried out in a certain way. Immunogenicity assays need to be designed in a manner that they can offer the required sensitivity. They should detect physiological consequences. They should also be able to factor in the possible risks, based on the target patient population profile.

We design the immunogenicity assays keeping these points in mind. It becomes possible to obtain data as to the type of immune response that the drug might elicit from humans. The result - researchers, can anticipate possible side effects of the drug with a higher degree of confidence.

Immunogenicity Assessment and ADA Assays

As per Government regulations, immunogenicity assessment is a necessity for biologics approvals. This includes reviewing the various immunogenicity testing studies and interpreting their results. In vitro immunogenicity assessment and animal testing are insufficient to understand immune responses in humans. So, the target population should also go through the immunogenicity investigation.

ADA assays are a critical part of immunogenicity assessments for the screening of therapeutic drug candidates. They help to measure the immune responses against the therapeutic proteins.

Immune responses might have varying consequences for therapeutic biologics. The effect can range from minimal to something critically adverse. It may invite fatal complications like anaphylaxis and rendering life-saving therapies ineffective. It might also neutralize endogenous proteins and make their functions non-redundant. Such an outcome could be crippling for a pharma research company. That is why, for approval of biologic or toxicology studies in drug development, it is important to have a regular and planned evaluation of immunogenicity.

Drug interference, sample matrix interference, or target interference might challenge immunogenicity assays. It is important to choose an accurate assay format and positive control. It is necessary to refine the assay to make it suitable during the drug development and post-marketing surveillance processes.

We employ a rigorous and tiered approach towards the measurement of ADAs and Nabs. Developing and validating qualitative and quantitative immunoassays are equally important. The initial focus is on identifying the antibodies bound to the biologic drug. After the screening of the samples, antibody assessment and confirmation of binding takes place. If the ADA samples are positive, we analyze them to detect the occurrence of neutralizing activity in a Nab assay.

Thus, immunogenicity can have a serious impact on the efficacy of a biologic and its safety. Adoption of the tiered approach and the consequent safeguards is important to minimize the immunogenicity risks of biologic drug development. This will result in safer products. Get in touch to know more about the latest research our teams have done in the field of immunogenicity testing.

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