Immunogenicity
Assays

Immunogenicity testing are complex and drug specific. Sword Bio has the expertise and experience to deliver on your ADA and Nab assays needs. We can support you from method development through sample analysis for nonclinical and clinical stages of your drug development.

The Sword Difference

At Sword Bio, our scientists have the experience and expertise to tackle the complexities that are a part of developing ADA and Nab assays, one of which is drug tolerance.
Our scientists have knowledge of immunogenicity of biotherapeutics as well as gene therapy vectors (AAVs) and can get you your information quickly.

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How Our Team Can Help

We have experience developing both bridging and direct-binding ADA, solution based Nab assays, as well as the more drug tolerant ACE and SPEAD formats.  Multiphased approach to include:

  • Method development, qualification, validation and sample testing support
  • Screening assay and cut point determination (95th percentile)
  • Confirmatory assay development (99th percentile)
  • Drug tolerance interference mitigation
  • Isotype evaluation
  • AAV vector immunogenicity screening
  • Solution based Nab assays
  • Cell-based receptor Nab assays
  • Pre-Clinical and Clinical services
  • Non-GLP or GLP

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