What is an immunogenicity assessment?

What is an immunogenicity assessment?

The goal of immunogenicity studies is to investigate presence of an immune response to the therapeutic protein and its clinical impact. Thus, the evaluation of immunogenicity should be based on integrated analysis of immunological, pharmacokinetic, pharmacodynamic, as well as clinical efficacy and safety data.

Is immunogenicity good or bad?

Vaccines work by stimulating the immune system to produce antibodies against a foreign agent, a weakened version of a disease germ, creating antibodies to that disease, so that the body can protect itself from that disease ever after. But with biologic drugs, immunogenicity is a bad thing.

How do you test for immunogenicity?

Currently, the most technically feasible approach for testing a product’s immunogenicity involves measuring antibodies specifically generated against the product. In clinical studies, therefore, detection and characterization of antibodies is important to understand the efficacy and safety of a BTP.

What are the effects of immunogenicity?

Many factors influence the immunogenicity of proteins, including structural features (sequence variation and glycosylation), storage conditions (denaturation, or aggregation caused by oxidation), contaminants or impurities in the preparation, dose and length of treatment, as well as the route of administration.

What causes immunogenicity?

Unwanted immunogenicity is an immune response by an organism against a therapeutic antigen. This reaction leads to production of anti-drug-antibodies (ADAs), inactivating the therapeutic effects of the treatment and potentially inducing adverse effects.

What is the difference between antigenicity and immunogenicity?

The term immunogenicity refers to the ability of a substance to induce cellular and humoral immune response, while antigenicity is the ability to be specifically recognized by the antibodies generated as a result of the immune response to the given substance.

How can I improve my immunogenicity?

Improvement of immunogenicity of a protein Ag may be achieved by an appropriate manipulation of the molecular and/or cellular events that govern the immune response. In the case of a thymus-dependent Ag, the associated humoral response requires induction of both B and T helper cells (1).

Is Ada an immunogenicity?

What is Therapeutic Protein Immunogenicity? The immunogenic response generally includes both cellular (T cell) and humoral (antibody) arms of the immune response, however we usually measure antibodies. Antibodies directed against TP (anti- drug antibodies, ADA) may consist of IgM, IgG, IgE, and/or IgA isotypes.

How do you reduce immunogenicity?

Accordingly, a possible practical approach for reducing immunogenicity involves the removal of B cell epitopes. In this case, reducing the affinity between the antigen and the B cell receptor may reduce B cell activation, even though the T cell will still be activated.

How would you improve the immunogenicity of a subunit vaccine?

Common approaches to enhance the immunogenicity of subunit vaccines include polyvalent antigen display strategies, the use of adjuvants, etc. The polyvalent antigen display strategy requires the use of a scaffold, which can be protein-based or some other materials.

What is cell mediated immunity?

Cell mediated immunity (CMI) is that arm of the immune response that does not involve antibodies but rather incorporates the activation of macrophages and NK cells enabling them to destroy intracellular pathogens, the production of antigen-specific CD8 cytotoxic T-lymphocytes (CTLs), and the release of various …