Overview of Immunogenicity Testing in COVID-19 Biologics Drug Development

by Manish Singh

Robust immunogenicity testing is the backbone of drug development and approval process.

Immunogenicity as the capacity of a substance to produce an immunity response. For a biopharmaceutical drug development program to be triumphant and safe, a successful immunogenicity testing is critical.

Peptides, enzyme therapies, therapeutic antibodies, and their combinations can bring out immune responses. Clinical scientists test the responses on the parameters of safety and effectiveness.

Obviously, remedial drugs and preventive vaccines for COVID-19 will also go through robust immunogenicity tests.

The Corona Attack

The Coronavirus, or Covid-19, has struck the entire planet with an unimaginable ferocity. The death toll is mounting steadily and the rates of infection don’t show any signs of abatement, either. Governments have undertaken sporadic measures to contain the virus, but they all haven’t proved to be much effective.

The need of the hour is to develop a drug that can cure or at least, prevent the virus. Clinical scientists around the world are working round-the-clock for this. This effort to develop the Covid-19 biologics drug that brings benefits to such a large number of patients will transform the healthcare landscape once it’s successful.

Many serious clinical conditions – like cancer, rheumatoid arthritis, etc. – became possible to be treated with biologics development, brought about by successful immunogenicity testing.

Immunogenicity Testing

Immunogenicity assays show a way that can measure the possible immune responses that biologics might provide. It might happen that a single biologic needs a group of assays to provide a possible representation of the potential immune responses from biologics and biosimilars.

There are certain FDA guidelines as to how to design immunogenicity assays. They need to have the required sensitivity, are not carrying any confounding interference, and can point out physiological consequences. They should also be able to take into account the possible risks based on the target patient population profile.

Clinical scientists need to understand what type of immune response a drug might produce in humans. They also need to determine its strength. Thus, they design the assays keeping the above factors in mind. Immunogenicity testing is an absolute necessity in a biologics development program. Any small alteration in manufacturing biologics can make a big change in their immunogenicity profile.

During the process of drug development, there is a three-step approach to determine the immunogenicity of a biologic – i) design a screening assay to almost eliminate false-negatives, ii) a strict confirmatory assay that minimizes false-positives, and iii) various ADA assays.

Immunogenicity Analysis

An antibody assay measures the antibodies that make up the immune response. Some biologics, confirmatory and titer components are enough to create an immunogenicity profile. To detect antibody-antigen complexes, the ELISA (enzyme-linked immunosorbent assay) also proves to be quite useful.

All these tests have a specific goal in mind. They want to foresee the clinical effect that a patient immune response produces to biologics. Thus, immunogenicity plays an important role in drug development. And, keeping the present pandemic scenario in mind, its role in Covid-19 biologics drug development (that is both safe and efficient) can’t be overemphasized.

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