We evaluate drug immunogenicity and its impact on PK and PD by measuring ADA levels with a tiered approach (screening assay followed by a confirmatory assay). ADA Bioanalysis for Anti-HER2 Immunogenicity Assessment ADA tested using screening assay, confirmatory assay...
We use different assay platforms and develop fit for purpose, site-specific, and region-specific assays. ELISA Quantification of Humanized mAb Case Study: Peptide Assay Triptorelin, peptide, M.W. 1311.5 We share a strong BA method development team with the GLP and...
We have developed multiple assays targeting the different war heads of the bispecific antibody and the Fc region. Similar PK profile in SD rat for both antibodies Fast clearance in monkey Bispecific Ab – Non-specific PK in Rats and Targeted Mediated Disposition in...
We offer PK analysis and PKPD modeling for monoclonal antibodies with either affinity-based ligand binding assays or LCMS/MS-based quantification. High Quality In-Life and BA Purpose: to evaluate PK property of mAb after IV infusion administration in cynomolgus...
