At Creative Biolabs, we understand that the development of a new antifungal drug is a complex and highly regulated process. A critical component of preclinical safety evaluation is the assessment of genotoxicity—the potential of a substance to damage genetic material. Such damage can lead to gene mutations, chromosomal aberrations, and other adverse effects, including carcinogenesis and heritable genetic diseases. Regulatory bodies worldwide, including the FDA, EMA, and ICH, require comprehensive genotoxicity data for all new drug applications (NDAs). Contact Us for a Customized Quote
Overview of Our Services
Our Genotoxicity Assessment Service is specifically designed to support the unique challenges of antifungal drug research. We provide a full suite of studies, from early-stage screening to definitive regulatory-enabling assays. Our expert team and state-of-the-art facilities ensure that you receive accurate, reliable, and interpretable data, empowering you to make informed decisions and accelerate your path to clinical trials and market approval.
Detailed Scope of Services
We offer a comprehensive "battery" of genotoxicity tests that adhere to international regulatory guidelines. This includes both in vitro and in vivo assays to provide a complete picture of a compound's genotoxic potential.
Workflow
Service Details
Samples
Deliverables
Turnaround Time
In Vitro Services
In Vitro Genotoxicity Assays
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Bacterial Reverse Mutation Test (Ames Test): This assay is a foundational test for detecting gene mutations. It uses specific strains of Salmonella typhimurium and E. coli that are auxotrophic.
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In Vitro Mammalian Cell Micronucleus Test: This assay detects chromosomal damage (clastogenicity) and spindle damage (aneugenicity) by measuring the frequency of micronuclei.
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In Vitro Mammalian Chromosome Aberration Test: This test directly identifies structural chromosomal aberrations (e.g., breaks, translocations, deletions) in cultured mammalian cells.
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Mouse Lymphoma TK Assay: This assay detects gene mutations and chromosomal changes at the thymidine kinase (TK) locus in L5178Y mouse lymphoma cells.
In Vivo Services
In Vivo Genotoxicity Assays
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In Vivo Mammalian Erythrocyte Micronucleus Test: Considered the "gold standard" in vivo assay, this test detects chromosomal damage in immature red blood cells (erythrocytes) in the bone marrow or peripheral blood of rodents.
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Comet Assay (In Vivo DNA Damage Assessment): The Comet assay is a sensitive method for detecting DNA damage, such as single- and double-strand breaks, in a variety of cell types from treated animals.
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Transgenic Rodent Somatic and Germ Cell Gene Mutation Assays: These advanced assays are used to follow up on positive in vitro findings or to provide weight-of-evidence for a compound's safety.
Samples
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Chemical/Biological Identity: Full chemical name, CAS number, structure, and any known impurities.
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Purity & Stability: Certificate of Analysis (CoA) documenting purity and stability.
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Safety Information: Safety Data Sheet (SDS) and any known toxicological data.
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Quantity: We will specify the required amount based on the study design. For early screening, a small quantity (e.g., < 50 mg) is often sufficient.
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Solubility and Vehicle: Information on solubility in various solvents (e.g., DMSO, water) is critical for formulation.
Deliverables
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A detailed, compliant Final Study Report.
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A summary of all raw data (e.g., cell counts, micronucleus frequencies, colony counts).
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A Certificate of Analysis for the test article as received by our facility.
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A comprehensive interpretation of the results and their regulatory implications.
Turnaround Time
Turnaround times are dependent on the specific assays and study design.
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Screening Assays (Non-GLP): 2-4 weeks
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Standard Battery (Ames, In Vitro MN, In Vivo MN): 8-12 weeks
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Complex or Follow-Up Assays: As per the detailed project plan.
Ready to discuss your project? Let us get in touch and explore how our consulting services can help you achieve your goals.
Mechanism of Action & Necessity
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Direct DNA interaction: The compound or its metabolites can bind to DNA, forming adducts or causing single/double-strand breaks.
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Oxidative stress: The compound can induce the production of reactive oxygen species (ROS), which can damage DNA.
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Disruption of DNA replication or repair: The compound can interfere with enzymes like DNA topoisomerases or polymerases, leading to chromosomal damage.
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Interference with the mitotic apparatus: The compound can disrupt the spindle fibers, leading to numerical chromosomal aberrations (aneuploidy).
For antifungal drugs, genotoxicity assessment is particularly important. Many antifungal agents target cellular processes that are also present in mammalian cells, albeit with structural differences (e.g., cell wall synthesis vs. human cell membranes, or differences in enzymes). Off-target interactions can lead to genotoxic effects, posing a significant safety risk. Early and thorough testing is crucial to identify and de-risk promising candidates, ensuring patient safety and avoiding costly failures in later development stages.
Our Advantages
Scientific Expertise
Our team of board-certified toxicologists and genetic toxicologists provides unparalleled scientific guidance, from study design to data interpretation.
Integrated Solutions
We can integrate genotoxicity testing with other preclinical safety assessment services, such as general toxicology and safety pharmacology, for a streamlined and cost-effective approach.
State-of-the-Art Technology
We utilize advanced, high-throughput technologies and validated assays to provide accurate and efficient results.
Exceptional Communication
We believe in a collaborative partnership. We provide regular updates and are readily available to address your questions.
Applications
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Pharmaceutical and Biotechnology Companies: Small to large-scale companies developing novel antifungal small molecules, biologics, or advanced therapeutic modalities.
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Academic Research Institutions: Researchers in need of high-quality, reliable genotoxicity data to support their academic publications or patent applications.
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Formulation Developers: Companies creating new drug formulations for existing antifungal agents that require re-evaluation for safety.
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Generic Drug Manufacturers: Companies needing to establish bioequivalence and safety for their generic products.
Your next breakthrough is just a conversation away. Let's talk about your challenges and find a custom solution together.
FAQs
Why is genotoxicity assessment required for antifungal drugs?
Genotoxicity testing is a mandatory part of preclinical safety assessment for all new drugs, including antifungals. It is crucial for identifying potential carcinogenicity or heritable genetic damage risks to future patients.
Can I perform a subset of the assays, or do I need the full battery?
For regulatory submission, a standard battery of tests is typically required. However, for early-stage compound screening, we can design a non-GLP package with a subset of assays to help you quickly de-risk your lead candidates.
What if my compound is positive in an in vitro assay?
A positivein vitro result does not automatically mean a compound is unsafe. We provide expert follow-up strategies, such as conducting the in vivo micronucleus test or other mechanistic assays, to determine if the in vitro finding is relevant in a whole-organism setting.
How do you handle and formulate my sensitive or difficult-to-dissolve compound?
We have extensive experience with a wide range of compounds. Our team will work with you to find a suitable vehicle and formulation method to ensure accurate and consistent dosing for the study.
