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.
Brochures
Process development, analytical development, and GMP testing and release services
Explore the analytical and bioanalytical services Prolytix provides to support large molecule drug discovery and development, from product characterization through GMP release. Capabilities include analytical method development, critical quality attribute testing, process development, stability testing, and bioanalytical assays such as pharmacokinetics, anti-drug antibody, neutralizing antibody, potency, and thrombin generation assays. Prolytix also offers GMP-compliant release testing and lifecycle management of critical reagents.
Resource details:
Resource type: Product brochure
Page count: 2
Read time: 3 mins
