Immunogenicity
R&D Research & Development
Immunogenicity assessment services for biologic therapeutics.
Immunogenicity is a critical safety and efficacy consideration for all biologic therapeutics. The potential of a therapeutic to elicit an unwanted immune response—from the transient formation of anti-drug antibodies (ADAs) to the development of neutralising antibodies (NAbs) that may compromise therapeutic efficacy—must be rigorously assessed and monitored throughout the entire drug development lifecycle.
AMSbiopharma provides validated immunogenicity assessment services for monoclonal antibodies (mAbs), bispecific antibodies, Fc fusion proteins, therapeutic enzymes, therapeutic peptides, gene therapy vectors, and advanced therapy medicinal products (ATMPs).
All assays are developed and validated in accordance with the EMA Guideline on Immunogenicity Assessment of Therapeutic Proteins, relevant FDA guidance documents, and applicable ICH guidelines.
Binding Anti-Drug Antibody (ADA) Assays
The detection of anti-drug antibodies (ADAs) is the cornerstone of immunogenicity assessment programmes. A well-designed and properly validated ADA assay must detect anti-drug antibodies with sufficient sensitivity and drug tolerance to generate clinically meaningful data while maintaining the specificity required to accurately distinguish true positive responses.
AMSbiopharma develops and validates binding ADA assays using the tiered testing approach recommended by the EMA and the FDA, comprising screening, confirmatory, and antibody titre assays. Assay formats are selected according to the characteristics of the therapeutic molecule, and assay cut points are established using the statistical approaches recommended in current regulatory guidance.
Key analytical capabilities
- Tiered ADA testing strategy: screening, confirmatory, and antibody titre assays
- Applicable to monoclonal antibodies (mAbs), bispecific antibodies, therapeutic peptides, and advanced therapy medicinal products (ATMPs)
- Full assay validation covering sensitivity, drug tolerance, and specificity
- Documentation aligned with EMA and FDA immunogenicity guidelines