Immunotoxicity and Immunogenicity for Biologics

Evaluation of immunogenicity in human is a critical component in the clinical development of new biological entities (NBEs). With the rapid advancement of immunotherapy, either for oncology or other indications, assessment of immunotoxicity has also become an integral component of these programs. Our bioanalytical team provides services to support clinical immunogenicity and immunotoxicity evaluation.
 

  • Immunogenicity method development, validation and sample analysis for anti-drug-antibodies (ADAs) and neutralizing antibodies, including screening, confirmation, titration, isotyping and neutralization
  • Immunotoxicity assessment by biomarker assays (chemokines/cytokines, CD biomarkers)
  • Immunophenotyping

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