Immunogenicity & Neutralizing Antibodies

Immunogenicity refers to a drug-elicited anti-drug immune response. All macromolecules are potentially immunogenic. Sometimes compounds with molecular weights as low as 1,000 Daltons, such as penicillin or sulfonamides, may also elicit an immune response, but all severe immune responses, including immediate hypersensitivity responses and neutralizing antibody responses, must be avoided.

Immunogenicity can be either non-neutralizing or neutralizing. While a non-neutralizing immunogenicity may not have negative effect on the pharmacodynamics of the drug, neutralizing immunogenicity can deactivate drug activity and alter drug clearance, plasma half-life and tissue distribution. Thus, immunogenicity testing is important both to the safety and efficacy of the product.

Immunogenicity testing and associated services provided by QPS include:

• Preparation of antigen-protein conjugates for plate coating

• Method development and validation using ELISA format

• Screening for positive responses in study samples

• Confirmation test for samples displaying positive responses during screening

• Titering of confirmed positive samples to determine the relative degree of antigenicity

• Detection and determination of various classes of antibodies (e.g., IgG, IgM, etc.)

• Neutralizing antibody assays