Antibody-Drug Conjugates (ADCs) are an advanced class of therapeutics that combine the targeting precision of antibodies with the powerful efficacy of cytotoxic drugs. By linking antibodies, small molecule drugs, peptides, and other functional molecules, ADCs deliver targeted therapy directly to diseased cells with minimal impact on healthy tissues.
At InnoStar, we have built a comprehensive, regulatory-recognized non-clinical evaluation system tailored to the unique challenges of ADC development. With a proven track record of supporting over 150 ADC R&D projects, including many first-in-class innovations, InnoStar is a trusted partner for your ADC development journey.

Our Comprehensive ADC Service Platform
Early Screening Strategies
-Plasma stability analysis
-Intracellular payload release profiling
-Lysosomal and acidified liver S9 metabolic stability studies
-Multi-species pharmacokinetic (PK) assessment
-Early-stage in vitro and in vivo pharmacology research

Non-Clinical Pharmacokinetics
-In Vivo Pharmacokinetics
Evaluation of drug metabolism following single and multiple doses; high-sensitivity detection and analysis of total antibody, ADC, and free payload in plasma/serum.
-In Vitro Metabolic Stability
Metabolism studies using liver cells and microsomes to identify and characterize drug metabolites and evaluate stability.
-Drug Interaction Studies
Comprehensive analysis of CYP inhibition (including time-dependent), CYP phenotyping, enzyme induction, and transporter interactions.

Non-Clinical Safety Evaluation
-Safety Pharmacology
Assessment of potential impacts on cardiovascular, respiratory, and central nervous systems.
-General Toxicology
Long-term toxicity evaluations customized to the unique characteristics of ADCs, including antibody, linker, and payload components, with toxicokinetic support.
-Genotoxicity & Reproductive Toxicity
Standard and specialized testing for genetic and reproductive safety.
-Carcinogenicity Assessment
Conducted based on ADC-specific attributes and regulatory guidance.
-Immunogenicity & Immunotoxicity
Full immune safety evaluations, including immunogenic response profiling.
-Phototoxicity & Tissue Cross-Reactivity
Studies on light-induced toxicity and cross-reactivity with healthy tissues.
-Formulation Safety
Assessment of formulation safety and stability under various conditions.

 Clinical Bioanalysis
-Biomarker Analysis
Evaluate drug exposure–efficacy and exposure–safety relationships. Validated detection platforms for cytokines (e.g., TGF-β, chemokines) help optimize study timelines and reduce costs.
-Free Payload Bioanalysis
Quantitative detection of cytotoxic payloads in biological samples using ultra-sensitive LC-MS/MS technology.
-ADC & Total Antibody Analysis
ELISA, ECL, and other validated platforms for quantifying ADCs and total antibodies.
-Immunogenicity Testing
Advanced platforms (ELISA, ECL, cell-based assays) to detect anti-drug antibodies and evaluate immune responses.
-Target Antigen Expression Analysis
Tissue or tumor microenvironment analysis using IHC, mIHC, or mIF platforms.

Project Experience
•Completed & Ongoing Projects: Over 150 ADC projects, including monoclonal, bispecific, bimolecular, and non-oncology ADCs
•Regulatory Successes: 40+ NMPA IND approvals and 15+ FDA IND approvals
•Antibody Targets: MSLN, HER2, CLDN18.2, CD38, CD20, C-MET, TROP-2, BCMA, and more
•Payloads: MMAE, MMAF, DM1, SN38, DUO-5, PBD, Exatecan, DXd, topoisomerase inhibitors, DNA disruptors, etc.
•Target Molecules: Claudin18.2, CD70, CD38, HER2, CD276, TROP2, ROR1, among others

Partner with InnoStar
Whether you're advancing a first-in-class ADC or optimizing a next-generation candidate, InnoStar offers end-to-end support to accelerate your development pipeline and ensure regulatory success.
(put a contact link here) Contact us today to learn how we can support your ADC program.