Technical Services

Drug Toxicology Evaluation Technical Services

I. Introduction to Drug Toxicity

Drug toxicity refers to harmful effects on the body caused by drug exposure at doses exceeding therapeutic levels or during prolonged use, potentially leading to organ dysfunction or tissue damage. Toxicology evaluation is a critical step in drug development, aiming to assess potential risks and ensure drug safety and efficacy. Toxicity may involve multiple organ systems (e.g., liver, kidneys, nervous system), necessitating comprehensive toxicological studies to characterize safety profiles.

II. Detection Models

1. Adherent Primary Hepatocytes

• Species: Human, monkey, dog, rat, mouse.

• Applications:

• Simulate in vivo drug metabolism to evaluate metabolic stability, toxicity, and metabolite profiles.

2. 3D Liver Spheroids (Mini-Liver)

• Model: Co-culture hepatocytes and non-parenchymal cells (NPCs) under 3D conditions to form physiologically relevant liver spheroids.

• Advantages:

• Recapitulates liver architecture and long-term functionality.

• Ideal for chronic toxicity studies and mechanistic investigations.

3. Organ-on-a-Chip

• Technology: Multi-channel microfluidic cell culture systems that emulate organ-level physiology.

• Applications:

• High-throughput toxicity screening.

• Complex toxicity mechanism studies (e.g., multi-organ interactions).

III. Service Credentials, Facilities, and Team

• GMP-Compliant BSL-2 Lab:

• Registered with the National Health Commission (卫健委) for handling HBV, lentiviruses, and human/animal samples.

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• Advanced Equipment (Total value: RMB 20+ million):

• Confocal microscope, fluorescence-activated cell sorter (FACS), ultracentrifuges, real-time qPCR systems.

• Expert Team:

• Ph.D. in Virology, Wuhan Institute of Virology, Chinese Academy of Sciences.

• 14+ years of expertise in liver research.

• Principal investigator for 7 national/provincial grants (NSFC, Guangdong DST, Shenzhen STIC).

• 10+ first/corresponding-author SCI publications.

• AIMBE Fellow, National Young Thousand Talents Program awardees, and Shenzhen High-Level Talent Awardees.

• Dr. Ming Zhou:

Ph.D. in Virology, Wuhan Institute of Virology, Chinese Academy of Sciences.

14+ years of expertise in liver research.

Principal investigator for 7 national/provincial grants (NSFC, Guangdong DST, Shenzhen STIC).

10+ first/corresponding-author SCI publications.

IV. Case Studies

Case 1: A Dongguan Biopharmaceutical Company

• Objective: Evaluate hepatotoxicity of a drug candidate using adherent primary hepatocytes.

• Results:

• High-dose exposure significantly reduced cell viability (↓~60%) and induced apoptosis (↑3-fold vs. control).

• Conclusion: Potential hepatotoxicity risk identified, prompting dose adjustment in preclinical development.

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Case 2: A Guangxi Research Institution

• Objective: Screen cardiotoxicity of a candidate drug via organ-on-a-chip.

• Results:

• Heart-on-a-chip showed marked contractility impairment (↓40%) and cardiomyocyte apoptosis (↑2.5-fold).

• Conclusion: Significant cardiotoxicity risk detected, guiding structural optimization of the drug.