Non-Clinical DMPK Services for ADC

ADC DMPK Study Framework

DMPK Support Across ADC Development

Study Area	Lead Discovery and Optimization	Pre-Clinical Candidate Selection and Evaluation	IND-Enabling Studies and Mass Balance Studies
Biotransformation	01Mechanisms of payload release from ADCs in liver S9, lysosomes, and target-expression cells 02Plasma metabolite profiling	01Payload metabolism in hepatocytes and microsomes from different species 02Tissue distribution of radiolabeled ADCs in rats and tumor-bearing mice 03Metabolic enzyme mapping studies	01ADME studies of radiolabeled payload in animals 02ADME prediction in humans 03Definitive metabolic enzyme phenotyping
In Vitro ADME/DDI	01Payload lysosome stability 02Log D and permeability assessment of new payloads 03Metabolic stability studies of payloads 04Protein binding analysis of payloads 05Payload hERG test 06Plasma stability studies of ADCs, including payload release and DAR value changes	01Payload CYP inhibition and induction 02Payload transporter substrate/inhibitor analysis 03Payload P-gp/BCRP substrate analysis	01Prediction of DDI risk of ADC in humans using PBPK models 02Plasma stability studies of ADCs, including payload release and DAR value changes
Bioanalysis/PK	01PK screening of ADC and payload in rodents 02PK studies of antibody, ADC, and payload in pharmacological models 03DAR analysis in PK samples	01PK/TK studies of antibody, ADC, ac-payload, and unconjugated payloads in animals 02Immunogenicity studies in animals 03Biomarker exploration	01DAR analysis in PK/TK samples

Advantages

01Identification of Unknown Small Molecules: Non-targeted LC-HRMS methods identify unknown small molecules containing payloads released from ADCs and their metabolites.

02Comprehensive ADC Stability Studies: Investigate lysosomal stability, payload release in biological matrices, ADC concentration changes, and DAR variation.

03Our DMPK platform ↗ supports payloads, small molecules, peptides, biologics, and ADCs with flexible study design.

04Complete Transporter Evaluation Platform

05Experience in Animal Radioisotope ADME Studies

06Experience in Bioanalytical Assay Development

Mini Case Studies

LC-HRMS Analysis of Metabolites Containing Different Forms of Payload Released from Uncleavable ADC

LC-HRMS analysis provides insight into metabolites formed from uncleavable ADCs. Identifying different metabolic forms of released payload supports thorough metabolic characterization and ADC design optimization for stability, efficacy, and safety.

LC-MS Monitoring of DAR Changes and Plasma Stability of DS-8201 in Mice

For the HER2-targeting ADC DS-8201, this evaluation monitors DAR changes over time and plasma stability of payload and antibody components. The study supports early assessment of linker and molecular stability through analysis of free small-molecule toxins, conjugated toxins, conjugated antibodies, total antibodies, and DAR values.

Quantitative Analysis of DS-8201 and Trastuzumab Using LC-MS and Comparison with ELISA

Our LC-MS-based quantitative method for DS-8201 and trastuzumab provides results consistent with ELISA and supports biologics quantification in diverse study settings. The comparison demonstrates a reliable approach for comprehensive ADC and antibody analysis.

Related ADC Discovery Services

01Antibody/ADC in vitro Screening and Evaluation ↗ 02In vitro Bystander Effect Assays ↗ 03ADC-Focused CDX Models ↗ 04ADC Payload Screening and Profiling ↗

Target Based Assays

Cell Based Assays

Featured Services

In Vitro Safety Assessment

In Vitro Immunology Assays

In Vivo Pharmacology

DMPK

Service Portfolio

Featured Services

Non-Clinical DMPK Services for ADC

Contact Us