Immunogenicity Test Service

Immunogenicity is the ability of a particular substance, such as an antigen or epitope, to induce an immune response in the body of a human or animal. Immunogenicity assessment is integral to biologic drug development. Biotherapeutics such as proteins, antibodies, conjugated peptides and oligonucleotides can induce an adverse immune response in the body, leading to the development of anti-drug antibodies (ADAs), which can potentially threaten patient safety (causing allergy, autoimmunity, etc.). ADAs with neutralizing capacity are called neutralizing antibodies (NAbs). NAbs can reduce the efficacy of drugs by inhibiting their biologic activities. Assessment of ADAs as well as NAbs form the basic part of immunogenicity testing. Profacgen provides immunogenicity assay to test the ADAs and NAbs generated in the host organism upon biologic drug usage, and can best help our customers accelerate their drug discovery and development programs.

We offer immunogenicity determination utilizing a two-step approach for ADA evaluation and NAb test. The first step is focused on detecting ADAs that bind to the sample. After screening for the presence of ADAs and confirmation of specific binding, antibody titer assessment is performed next for ADA quantification. Immunogenicity assessment of NAb activity is performed by cell based assay or competitive ligand binding assay. Our scientists are experienced in the development and validation of qualitative and quasi-quantitative immunoassays. Our immunogenicity laboratories are equipped with well-established immunoassay platforms such as Enzyme-Linked Immunosorbant Assay (ELISA), Radioimmunoassays (RIA), Electrochemiluminescence (ECL) and cell-based neutralization assays.

Our Immunogenicity Assessment Services include:

•   Development and validation of qualitative and quasi-quantitative assays for total antibody (screen and titer), including confirmatory assay as well as statistical analysis.
•   Various assay methods available: direct or bridging ELISA, ECL or RIA.
•   Development and validation of cell-based assays (various readouts including cell proliferation, cell death, etc.), receptor binding assays or competitive ligand binding assays for detection of NAbs.

Our strength in professional assay design and implementation

The measurement of immunogenicity is complex as it depends on many aspects. Appropriate assay strategy has to be selected specifically for each project. A generic approach for the assessment of immunogenicity is usually not feasible. Challenges in appropriate assay selection include the evaluation of the presence of ADAs prior to the initiation of the treatment (pre-existing antibodies) or cross-reactivity of ADA of different isotopes, possibly leading to hypersensitivity reactions.

Profacgen can be your partner for developing immunogenicity assessment programs as we have extensive experience and knowledge in this field. Each project presents its own unique challenges, and our scientists will work closely with you to ensure that all specific requirements for the program are met. Through efficient management and proactive communication, we will conduct tailored assay development, ensure a scientifically sound method validation, and eventually help you meet all immunogenicity testing requirements.

Please feel free to contact us for more details of our immunogenicity test service.