Immunogenicity Assays
Solutions
Off the shelf fully validated assays
Proprietary fingerprinting technology (Intelli.b TM) for biosimilar antibody characterization
Potency assays
Antibody functionality testing
Immunogenicity profiling and prediction
Regulatory ready biosimilar package
Integrated Summary of Immunogenicity (ISI) document by molecule
Immunogenicity Assays: de-risk your molecule with reliable immunogenicity assessment
For the last several decades, unwanted immunogenicity has continued to be a predominant theme for biological products due to the serious consequences that can occur. The assessment of immunogenicity is scientifically and technically challenging. The regulatory thinking in this area is also fast evolving. Developing quality assays to support immunogenicity assessment requires both technical expertise and up to date regulatory knowledge.
Somru scientists have extensive experience in developing immunogenicity assays to support various modalities at different stages of drug development.
For our comprehensive immunogenicity solutions please visit our Immunogenicity Solution Center.
The road to biosimilarity is paved with successful immunogenicity prediction and confirmation.
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