Immunogenicity

免疫原性分析

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...
Immunogenicity

蛋白质和肽类分析

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...
Immunogenicity

双特异性抗体分析

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

抗体药物偶联物分析

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...
Immunogenicity

单克隆抗体分析

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...
Immunogenicity

• 生物分析

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...
Immunogenicity

• 早期毒理学

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...
Immunogenicity

药代动力学

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...
Immunogenicity

体外ADME

In-vitro ADME assays are critical for gaining insight into metabolism and potential drug interactions. Moving quickly through drug discovery and development saves you time and money. ChemPartner has industry-leading turnaround times for data to help our clients make...
Biologics CMC Analytical Development and Testing

Biologics CMC Analytical Development and Testing

ChemPartner’s analytical capability includes analytical development testing for non-GMP samples, GMP drug substances, and drug product release and stability testing as well as extended product characterization.  Our rapidly growing analytical development and quality...