Immunogenicity
Solutions
- In-silico Analysis
- T-cell epitope mapping system
- B-cell epitope mapping system
- Aggregation prediction
- Comparative analysis of hundreds of candidates
- Re-engineer drug candidates based on the in-silico recommendations
- Regulatory submission ready report for IND submission
- Immuno-Fingerprinting
- In-vitro assays to predict potential of cytokine storm
- In-vitro assays to predict cytokine storm
- Bioanalytical Assays
- Anti-drug antibody assays (three-tier)
- Neutralizing antibody assays
Unwanted Immunogenicity: From Risk Prediction and Assessment to Risk Mitigation and Management
The integration of comprehensive immunogenicity assessment using in-silico and in-vitro testing early in the biologics discovery process and development process can save significant time, money, and precious resources.
Somru has a toolkit of unique technologies that can help you understand the immunogenicity risk and potential mitigation strategy early on and enhance the quality and value of an R&D pipeline.
Immune Fingerprinting – In-Vitro Assays
Somru scientists have developed a fingerprinting approach that utilizes a suite of cell-based assays to generate a profile that can provide comprehensive insight into the potential immunogenicity of a drug candidate.
Immunoinformatics
We have developed a suite of immunoinformatics tools that enable the detection of immunogenicity risk early in the biotherapeutics development.
Cytokine Storm Assay
Cytokine release syndrome is an acute immune response initiated by a positive feedback loop between pro-inflammatory cytokines and immune cells. Assessing the risk of large molecules for the potential of acute or prolonged immunogenicity is required by the FDA, EMEA, and other global regulatory authorities.
The road to biosimilarity is paved with successful immunogenicity prediction and confirmation.
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