It is important to evaluate the immunogenicity of biotech products during preclinical studies or clinical trials. Using a custom approach we can develop and validate a specific sandwich ELISA for measuring total and specific immunoglobulins.
During the validation, we evaluate the assay cut-off point, sensitivity, intra-/inter-assay variability and sample stability.
Texcell also assesses the seroneutralization capacity for positive samples, such as using cell-based assays.
- Guideline on immunogenicity assessment of biotechnology-derived therapeutic proteins
- Draft Guidance for industry Assay development for immunogenicity testing of therapeutic proteins
- Guideline on immunogenicity assessment of monoclonal antibodies intended for in vivo clinical use
- Draft Guidance, Immunogenicity Assessment for Therapeutic Protein Products