Antibody drugs are a molecular form of precision treatment achieved by connecting different functional molecules (such as antibody fragments, effector molecules, etc.). Leveraging its expertise in antibody characteristics, InnoStar has systematically addressed research challenges and established a regulatory-compliant non-clinical evaluation system for antibody drugs. With global multi-center submission capabilities, InnoStar is committed to providing efficient and reliable R&D services to accelerate innovative drug development. we has cumulatively served over 300 antibody drug development projects, including multiple "first-in-class" innovations both domestically and internationally.

InnoStar Antibody Drug Solutions

Early Screening Strategies for Antibody Drugs
- Target binding affinity screening
- Preliminary effector function evaluation
- Serum protease stability testing
- Species cross-reactivity analysis
- Early in vitro/in vivo efficacy validation

Non-Clinical Pharmacokinetics
- In vivo pharmacokinetics: Investigation of drug metabolism following single and repeated dosing, with high-sensitivity detection of plasma/serum samples to analyze pharmacokinetic behavior of total antibody, antibody fragments, and free targets
- In vitro metabolic stability: Conducting protease/serum stability tests and antibody degradation product identification to evaluate degradation stability and metabolic profiles
- Drug interaction studies: Performing Fc receptor binding, complement activation, and ADCC/CDC effect studies to assess potential interactions with immune effector mechanisms

Non-Clinical Safety Evaluation
- Safety pharmacology: Assessing effects on critical system functions (cardiovascular, respiratory, and central nervous systems)
- General toxicology: Evaluating long-term dosing toxicity in animals, with study design and analysis based on target characteristics and Fc effector functions, accompanied by toxicokinetic investigations
- Genetic toxicity testing: Assessing potential genotoxicity risks based on antibody mechanisms
- Reproductive toxicity testing: Evaluating reproductive toxicity with focus on placental transfer and embryonic development impacts
- Carcinogenicity testing: Determining necessity based on target expression characteristics and relevant guidelines
- Immunogenicity/immunotoxicity: Assessing risks of anti-drug antibody production and immune hyperactivation
- Tissue cross-reactivity: Evaluating potential cross-binding with normal tissue antigens
- Formulation safety: Examining formulation stability and local injection tolerance

Clinical Bioanalysis
- Biomarker analysis: Evaluating drug exposure-efficacy and exposure-safety relationships to optimize development, utilizing validated cytokine/complement factor panels to maximize efficiency
- Free antibody fragment analysis: Employing ultra-sensitive ELISA/ECL platforms for quantitative analysis in biological matrices
- Total antibody and antigen-binding antibody analysis: Using ELISA/ECL platforms to quantify total antibody and antigen-binding activity
- Immunogenicity analysis: Conducting comprehensive assessment using ELISA, ECL, and cell-based neutralization assays
- Target antigen expression detection: Performing tissue expression distribution and tumor microenvironment analysis via IHC or mIHC/mIF

Project Experience
- Cumulatively completed: Over 300 new drug R&D projects
- Regulatory milestones: Nearly 120 NMPA IND approvals, including successful multi-regional submissions for 20+ China-U.S.-Europe IND applications

Partner with InnoStar for your antibody drug program and accelerate your path from discovery to approval with confidence.