Immunogenicity

Immunogenicity

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...
Immunogenicity

Proteins and Peptides

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...
Immunogenicity

Bispecific Antibodies

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...
Immunogenicity

Antibody Drug Conjugates

We offer multiple assay formats targeting the mAb portion, toxin, and the intact ADC drug. Single Intravenous Pharmacokinetics Study of Antibody Drug Conjugate (#1015) in Cynomolgus Monkey by Using Kadcyla® as Reference Target Mediated ADC Clearance in Cynomolgus...
Immunogenicity

Monoclonal Antibodies

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 monkeys...