Peptide drugs are a precise class of molecular therapies developed by linking functional molecules such as amino acids and chemical modifications. InnoStar has built a comprehensive, regulatory-recognized non-clinical evaluation system tailored to the unique challenges of peptide drug development.
With experience supporting nearly 60 peptide drug projects—including several first-in-class innovations—InnoStar provides reliable, globally aligned R&D services to help accelerate your peptide drug development from discovery to approval.

Our Capabilities

Early Screening Strategies for Peptide Drug Products

-Target Binding Affinity Screening
Measure peptide-receptor interaction strength and specificity.
-Plasma Protease Stability Testing
Assess peptide degradation in plasma and identify major cleavage points.
-Preliminary Cell-Level Activity Screening
Evaluate cellular activity and signaling pathway activation in vitro.
-Species Cross-Reactivity Analysis
Compare peptide target interaction across species to inform model selection.
-Early In Vivo Efficacy Validation
Use disease models (e.g., tumor-bearing mice, metabolic disease) to evaluate therapeutic potential.

Non-Clinical Pharmacokinetics

-In Vivo Pharmacokinetics
Analyze absorption, distribution, metabolism, and excretion (ADME) profiles after single/multiple doses.
-In Vitro Metabolic Stability
Perform enzyme degradation studies in plasma/tissue homogenates; identify metabolites.
-Drug Interaction Studies

Non-Clinical Safety Evaluation

-Safety Pharmacology
Evaluate impacts on cardiovascular, respiratory, and central nervous systems.
-General Toxicology
Conduct long-term toxicity studies with peptide-specific design and toxicokinetics.
-Genetic Toxicity Testing
Screen for genotoxic impurities related to peptide structure and synthesis.
-Reproductive Toxicity Testing
Focus on reproductive and hormonal impacts of peptide analogs.
-Carcinogenicity Assessment
Assess carcinogenic potential based on mechanism of action and exposure duration.
-Immunogenicity & Immunotoxicity
Evaluate anti-drug antibody formation and immune responses related to peptide aggregation.
-Local Toxicity Testing
Assess irritation, tissue compatibility, and permeability at administration sites.

Clinical Bioanalysis
-Biomarker Analysis
Correlate exposure with efficacy/safety; supported by LC-MS/MS biomarker detection.
- Free Peptide & Metabolite Analysis
Use ultra-sensitive LC-MS/MS for quantitative analysis in biological matrices.
-Total Peptide & Target-Bound Peptide Analysis
Quantify with ELISA, SPR, and other binding assays to support pharmacodynamics.
-Immunogenicity Analysis
Detect anti-drug antibodies via ELISA or cell-based assays.
-Target Receptor Expression
Analyze tissue/cell receptor expression using IHC or flow cytometry.

Proven Experience
-Nearly 60 peptide drug projects completed
- ~20 NMPA IND approvals
-Successful China–U.S. and China–Europe dual IND submissions

Why Choose InnoStar?
-Specialized expertise in peptide structure, metabolism, and safety profiling
-Robust global regulatory insight and IND preparation experience
-Integrated solutions from screening to bioanalysis and regulatory support

Partner with InnoStar to drive your peptide drug innovation forward—with scientific rigor and international confidence.