In Vitro Micronucleus Test

The in vitro micronucleus test, compliant with OECD TG 487, is a pivotal preclinical genotoxicity assay for early-phase lead compound safety assessment. Its core principle hinges on detecting micronuclei formation in interphase cells, which arise from acentric chromosome fragments or whole chromosomes failing to segregate properly during mitosis. When lead compounds induce clastogenic (chromosome breakage) or aneugenic (chromosome loss) effects, these aberrant genetic materials lag behind during cell division and form small, membrane-bound micronuclei in the cytoplasm. By quantifying micronucleus frequency in binucleated cells (blocked by Cytochalasin B to ensure completion of one mitotic cycle), the test accurately evaluates a lead compound's potential to cause chromosomal damage, providing critical genotoxicity data for prioritizing safe lead candidates.

Standard Experimental Workflow

PharmaAnalytica's in vitro micronucleus test follows a standardized, traceable workflow tailored for lead compound evaluation.

• Cell Culture and Seeding: We use validated cell lines (V79, CHO, or human peripheral blood lymphocytes) with continuous sterile subculture, seeding uniform cell suspensions into plates to ensure consistent growth.
• Compound Exposure and Metabolic Activation: Lead compounds are tested at 3–5 gradient concentrations (based on pre-cytotoxicity data), with concurrent negative (solvent) and positive controls, both with and without S9 metabolic activation to mimic in vivo drug metabolism.
• Cell Harvesting, Fixation, and Staining: Cells are harvested via centrifugation, treated with hypotonic solution, fixed with cold fixative, and stained with Giemsa to clearly visualize nuclei and micronuclei.
• Blind Scoring and Data Analysis: Trained analysts count micronuclei in binucleated cells, calculating micronucleus rates and comparing with controls to determine genotoxicity risk.

PharmaAnalytica's Technology Platform

PharmaAnalytica's In Vitro Micronucleus Test Service

Professional Technical Team

Our professional technical team consists of senior toxicologists and cell culture specialists with extensive experience in OECD 487-compliant testing; all technicians undergo rigorous training in sterile cell manipulation, blind scoring, and abnormal result troubleshooting to ensure standardized operations.

High Data Accuracy

We implement full-process quality control: calibrated instruments, strict environment monitoring (temperature, sterility), and dual-blind scoring by two analysts, with all raw data automatically archived and traceable to eliminate systematic errors.

One-Stop Service Support

Our comprehensive service covers end-to-end support: from sample receipt and solubility optimization to S9 activation testing, automated analysis via Xunshu systems, and GLP-compliant final reports with result interpretation, directly supporting IND submissions.

Cost-Effective & Fast High-Throughput Delivery

We offer high cost-effectiveness and fast turnaround, leveraging stable instrument clusters to reduce costs while maintaining test quality, accelerating early safety screening of lead compound libraries.

Backed by STEMart's robust analytical capabilities and standardized quality management, PharmaAnalytica provides reliable, efficient, and compliant in vitro micronucleus testing services, effectively identifying genotoxic lead compounds at an early stage and optimizing safety profiles for subsequent drug development.