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.
- EMA, 2007 Guideline on immunogenicity assessment of biotechnology-derived therapeutic proteins
- FDA, 2009 Draft Guidance for industry Assay development for immunogenicity testing of therapeutic proteins
- EMA, 2012 Guideline on immunogenicity assessment of monoclonal antibodies intended for in vivo clinical use EMA/CHMP/BMWP/86289/2010
- FDA, 2013 Draft Guidance, Immunogenicity Assessment for Therapeutic Protein Products