Peptide drugs

Chemical products Peptide drugs 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. Copyright © 2017-2021©Shanghai InnoStar Bio-tech Co., Ltd. All Rights Reserved. Created By VPABrand.com