Our laboratory employs various plate and cell-based technologies, such as TR-FIA, ECL, AlphaScreen, TR-FRET, RIA, SPR and ELISA, to assess the immunogenicity of biological drugs and vaccines.
SYRINX offers a multi-step approach when performing immunogenicity testing. After each step a report is sent to the customer for evaluation.
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1) Screening and confirmatory assay development and validation
Various assay designs are compared to find the best method to assess the total anti-drug antibodies (ADAs) using appropriate negative and positive controls. SYRINX can offer both heterogeneous and homogeneous assay formats. Homogeneous assay formats enable the detection of low-affinity antibodies that may have clinical significance. After the screening assay, a confirmatory assay is developed for the elimination of false positive samples.
Validation (in GLP)
The developed method is validated for its intended purpose. The following parameters will be among those validated in GLP according to the recommendations in recent white paper (Shankar G et al. Recommendations for the validation of immunoassays used for detection of host antibodies against biotechnology products. J Pharm Biomed Anal 48: 1267-81, 2008).
- Screening and confirmatory assay cut points
- Selectivity (recovery and drug tolerance)
- Matrix effect
- Hook effect
- Sample dilution (titration)
- Ruggedness and robustness
The list of parameters may vary depending on the underlying scientific or technical principles of the method used.
2) Neutralizing antibody (NAb) assay development and validation
Depending on the biological activity of the drug a functional assay is developed to assess the neutralizing activity of ADAs. We will test various cell lines to find the best alternative to measure the desired endpoint specific to the drug in question. The endpoint may be either an early or a late signaling event triggered by the drug. When applicable, functional ligand binding assays may be developed. We will create a cell bank with the lowest possible passage number to ensure that the measured function is not changed due to spontaneous recombinant mutations in the cell line.
Validation (in GLP)
The chosen method will be validated for its intended purpose including the parameters as listed in the screening assay validation.
3) Bioanalytical studies (in GLP)
Preclinical or clinical study samples will be analyzed and results reported according to GLP guidelines using the validated methods. Samples that have been shown to have ADAs will be further titrated to quasi-quantitate the amount of binding and neutralizing ADAs in the sample.
If required, the antibodies can be further investigated and characterized using the labelfree surface plasmon resonance (SPR) technique. Biacore T200 instrument is available including the acid dissociation protocol specially designed for immunogenicity testing.