Unwanted Immunogenicity (ADA)
During preclinical studies or clinical trials, it is important to evaluate the immunogenicity of biotech products.
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, sample stability, and so on.
Texcell can also assess the seroneutralization capacity for positive samples.
Main Guidelines:
ICH S6 (CPMP/ICH/302/95) “Note for guidance on preclinical safety evaluation of biotechnology-derived pharmaceuticals”
EMEA/CHMP/BMWP/246511/2005 “Concept paper on guideline on immunogenicity assessment of therapeutic proteins”
FDA/CDER/Oct 2002 Guidance for Industry “Immunotoxicology evaluation of investigational new drugs”
Standardization Paper “Recommendation for the design and optimization of Immunoassays used in detection of host antibodies against biotechnology products” A.R. Mire-Sluis et al. / Journal of Immunological Methods 289(2004)1-16
FDA/CDER/May 2001 “Bioanalytical method validation”
ICH Q2(R1) 2005 (previously Q2A/B) “validation of analytical procedures: text and methodology”
