Sword Diagnostics, Inc.
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Immunogenicity Assays - Anti-Drug Antibody Assays
Whenever large molecular biologics (proteins) are administered to a patient, the patient can potentially develop antibodies to the therapeutic, known as anti-drug antibodies (ADAs). The detection, quantitation, and determination of the isotype of drug-induced ADAs are critical to the understanding of the etiology of these antibodies and the effect that ADAs may have on the efficacy of the patient’s treatment.
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At Sword, our scientists have experience in the development and performance qualification of ADA methods that are designed to meet a client’s specific project needs.
We have experience developing both bridging and direct-binding ADA assay formats, and in all phases of ADA assay development, to include:
- Screening assay development and cut point determination (95th percentile)
- Confirmatory assay development (99th percentile)
- Method optimization interference mitigation
- Assay “fit-for-purpose” performance qualification