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Immunogenicity

Adverse patient responses to a biologic resulting in the development of anti-drug antibodies (ADAs) is a phenomenon known as immunogenicity. Because this immune response can adversely affect the safety and efficacy of a drug, assessments surrounding this event are critical in the preclinical development phase. A protein laboratory with an immunological research focus, B2S Life Sciences provides comprehensive and detail-oriented services for client interested in examining immunogenicity and ADA interaction assessments. Aligning with the latest regulatory guidance, our statisticians employ the well-integrated three-tier approach to define the immunogenicity profile of a prospective therapeutic. Our meticulous analyses coupled with expert data interpretation set an industry standard, and position B2S favorably within the screening and confirmatory cut point determination landscape. As such, we offer a vast range of immunogenicity support capabilities that include:

 

  • Preparation of immunogenicity risk assessment plans
  • Development of bioanalytical assays for detection of binding antibodies and neutralizing antibodies
  • Generation and characterization of custom immunoanalytical reagents (conjugates and surrogate antibodies)
  • Oversight of method validation and regulated bioanalysis at CROs
  • Statistical computation of immunogenicity cut points (screening, confirmatory, titer, and neutralizing antibodies)
  • Assay troubleshooting
  • Interpretation of clinical immunogenicity and report generation
  • Specialized ADME studies to investigate immunogenicity findings