Immunogenicity Assays
Immunogenicity assays are critical assessments that screen for potential anti‑drug antibodies (ADAs) and support product safety and efficacy. Prolytix supports partners with comprehensive immunogenicity method development, validation, and testing for preclinical and clinical phases of biotherapeutic development.
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Many biotherapeutics have the potential to generate unwanted immune responses in some patients. Unwanted immune responses, such as the production of anti‑drug antibodies, can be caused by a number of factors, including drug structure, patient disease state, and formulation.
Immunogenicity assays are critical assessments that screen for potential anti‑drug antibodies and support product efficacy. Prolytix provides immunogenicity method development, validation, and testing to support preclinical and clinical biotherapeutic development.
All testing is conducted in Prolytix’s GLP, GCLP, CLIA, and GMP analytical laboratories, which maintain an outstanding FDA and client inspection track record.
