Oncolytic Virus Immunogenicity Study Service
Immunogenicity assessment is a crucial step in antibody-based drug development, and it must be conducted during both the pre-clinical and clinical phases. Drugs with immunogenic potential may elicit adverse immune responses, notably the generation of anti-drug antibodies (ADAs) and neutralizing antibodies (NAbs). ADAs can trigger a robust immune reaction in patients, and in severe cases, may even jeopardize patient safety. NAbs, on the other hand, can neutralize the biological activity of therapeutic antibodies, thereby attenuating their efficacy.
Detection of Anti-drug Antibody
There are two main sources of immunogenicity. Endogenous immunogenicity comes from non-human amino acid sequences, human amino acid sequence variations, and modifications for efficacy enhancement or half-life prolongation (e.g., point mutations). Exogenous immunogenicity results from CMC (production processes, impurity/quality studies), materials, and transportation. Administration factors like route, frequency, and timing can also affect immunogenicity.
The immunogenicity test of biological drugs mainly includes the following three steps:
- Immunogenicity Screening: Detection of ADAs that recognize antibody-based protein drugs.
- ADA Confirmation: Protein drug competition assays are employed to verify the specificity of ADAs and eliminate false-positive results.
- ADA Characterization: Multiple analyses are conducted, including competitive ligand-binding analysis, subtype analysis, binding-stability analysis, epitope-specificity analysis, neutralization-ability analysis, etc.
Widely-utilized approaches in immunogenicity evaluation
When it comes to the detection of oncolytic virus immunogenicity, a diverse range of experimental methods are available for selection, with each method having its distinct foci, advantages, and disadvantages. The common experimental methods are summarized in the following table:
Tab.1 Experimental method commonly used to test immunogenicity.
| Method | Marker | Detection signal | Characteristics |
|---|---|---|---|
| Bridging ELISA | Enzyme labeling | The enzyme catalyzes the color development of the substrate | High specificity and sensitivity |
| Direct ELISA |
Convenient to operate, less non-specific binding |
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| Indirect ELISA |
High sensitivity, A variety of primary antibodies can be detected |
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| Radioimmunoassay (RIA) | Radionuclide | Intensity of radioactivity |
Extremely high sensitivity, Radioactive contamination |
| Electrochemiluminescence (ECL) | Electrochemiluminescence substrates | Optical signal intensity |
High sensitivity, Wide linear range, Rapid detection |
| Surface Plasmon Resonance (SPR) | No need for labeling | Change in Angle or intensity of reflected light |
No need for labeling, High sensitivity, Real-time detection |
| Enzyme-Linked Immunospot Assay (ELISpot) | Enzyme labeling | The enzyme catalyzes the color development of the substrate | Detect the secretion of cytokines |
| Immuno-PCR (IPCR) | Specific DNA sequences | PCR products |
Exceptionally high sensitivity, Relatively intricate experimental procedures Prone to yielding false positive outcomes |
Creative Biolabs boasts extensive expertise accumulated over many years in devising methods for evaluating the immunogenicity of oncolytic viruses. We are capable of formulating customized detection protocols tailored to the specific requirements of our clients. Our services encompass professional and expeditious immunogenicity assays, followed by the issuance of comprehensive test reports. Should you have any related requirements, please do not hesitate to contact us.