ChemPartner provides proficient pathological service including animal necropsy, tissue processing and embedding, blank section preparation, H&E staining, special staining, image collection, data analysis, and final reporting. Stained slides are reviewed and...
ChemPartner provides IND filing packages and helped file hundreds of US FDA submissions for our clients. Robust in vitro/in vivo ADMET packages in support of regulatory submissions Experienced in both US FDA and NMPA assay design requirements and...
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 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 ReferenceTarget Mediated ADC Clearance in Cynomolgus...
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...
ChemPartner has served many clients, not only in discovery research but also in regulated bioanalysis. We have a state-of-the-art mass spectrometer laboratory for small molecule/peptide bioanalysis and ELISA/MSD laboratory for large molecule bioanalysis. We have...
ChemPartner has served and prepared many clients in exploratory toxicology area so they start their GLP toxicology with confidence. We also use Derek software to predict potential genotoxicity. In vitro toxicology including hERG and AMES Tolerability/Non-GLP in vivo...
ChemPartner has conducted 120-150 PK studies per week and served many pharmacokinetics (PK) clients. AAALAC and OLAW accredited animal facilities with access to broad ranges of animal species State-of-the-art instruments Extensive experience in PK model development...
