Pre-Clinical Research
Non-clinical Safety Service
INTRODUCTION
Our platform is structured into eight specialized departments—including Pharmacology, PK & Bioanalysis, Toxicology, Quality Assurance, and Laboratory Animal Services—and two committees, such as the Institutional Animal Care and Use Committee. Over 50% of our staff hold senior or intermediate positions.
Equipped with nearly RMB 30 million worth of advanced instruments—including physiological telemetry systems, BIOPAC recorders, animal ultrasound, laser Doppler flowmeters, blood gas analyzers, flow cytometers, fully automated analyzers, and LC-MS/MS systems—we possess the full capability to conduct comprehensive pharmacology, pharmacokinetics, and safety evaluations for chemical drugs, biologics, traditional Chinese medicines, and select medical devices.
SCALE & EXPERIENCE
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500+Pharmacology Studies
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200+DMPK Studies
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500+Toxicological and Safety Evaluation Project
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120+Teams
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300+Facilities
DMPK & BA Platform
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Stability studies in biological matrices, including plasma, whole blood, tissues, and simulated gastric/intestinal fluids.
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Metabolic stability and metabolite profiling using systems such as multispecies microsomes, hepatocytes, and S9 fractions.
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Blood-to-plasma ratio and protein binding studies employing methods including equilibrium dialysis, ultrafiltration, and ultracentrifugation.
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CYP450 enzyme phenotyping via chemical inhibition and recombinant enzyme assays.
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CYP450 inhibition and induction studies (including human primary hepatocyte induction assays).
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Bidirectional permeability assays using Caco-2 cell models.
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Substrate and inhibition studies for efflux and uptake transporters.
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Absorption studies following single and repeated dosing, including plasma concentration-time profiles and bioavailability assessment.
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Tissue distribution studies covering heart, liver, spleen, lung, kidney, gastrointestinal tract, gonads, brain, adipose tissue, muscle, and other organs.
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In vivo metabolism studies in biological matrices such as plasma, bile, feces, and urine.
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Excretion studies, including biliary excretion as well as fecal and urinary elimination.
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Analysis method development and validation for TCM, chemical drugs, peptides, antibodies, and cell-based therapies.
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Toxicokinetic studies concomitant with repeat-dose toxicity testing.
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Toxicokinetic studies in support of reproductive toxicity evaluations.
Central Laboratory Service
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Method development and validation (compliant with ICH M10) for various platforms including LC-MS, ELISA, MSD, qPCR, and flow cytometry.
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Pharmacokinetic (PK) and anti-drug antibody (ADA) studies for antibodies, ADCs, peptides, and protein-based therapeutics.
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Pharmacokinetic (PK) and immunogenicity (ADA) studies for vaccines and nucleic acid-based drugs.
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Pharmacokinetic (PK) and immunogenicity (ADA) studies for cell and gene therapy products.
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Neutralizing antibody analysis, including antibody subtyping, epitope mapping, and affinity assessment.
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Immunotoxicity marker detection including cytokines, immunoglobulins, complement, and lymphocyte subsets.
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Metabolic and endocrine-related biomarker
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Tumor-associated biomarker
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Infection-associated biomarker
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Central nervous system-related biomarker
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Bone metabolism-related biomarker
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Chemokine
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Cell surface antigen
SERVICE FEATURES
- IVRT and permeation IVPT testing
- In vivo absorption and skin tissue distribution studies
- Isolation of epidermal, dermal, subcutaneous, and muscular layers in minipig skin using an automated dermatome
- Sequential sampling of skin and subcutaneous tissues in the same minipig via puncture sampling technique
- Completion of multiple safety evaluation studies for modified and generic topical formulations, supporting successful regulatory submissions
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Utilizing firefly luciferase as a reporter gene, stem cells are transfected in vitro via transgenic technology, and their in vivo distribution is tracked using the PE IVIS Lumina in vivo imaging system.
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An absolute quantitative qPCR method based on proprietary technology offers high specificity, sensitivity, and broad applicability at a low cost.
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Analytical methods for human-specific markers of bone marrow, adipose, cartilage, liver, pancreatic, cardiac, and osteogenic cells have been established, supporting the study of unintended differentiation of human-derived stem cells in animal models.
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High-throughput, automated, and reproducible nucleic acid extraction technology has been developed, delivering high yield and purity to ensure accurate quantitative detection.