Genetic Toxicology

As a service leader in cancer immunotherapy discovery and development, Creative Biolabs offers toxicological studies including genetic toxicology to facilitate your preclinical testing, thus moving your program efficiently forward to IND approval and market approval. Accurate analysis of the genetic toxicological results is vital to prevent potential risks of data leakage and program failure.

Genetic Toxicology Service

As a critical component of a complete safety assessment, genetic toxicological studies are designed and conducted to assess the potential risks of genetic mutations or chromosomal damages. It is conducted to determine whether further development is needed and, if so, what additional studies are needed to investigate and identify the relevance of any observed adverse effects. Based on different regulatory requirements for various therapeutic types, Creative Biolabs provides our clients with the most suitable in vitro and in vivo assays when necessary.

In Vitro Genotoxicity Assays

• ■ Bacterial Mutation Test
• ■ Mammalian Chromosome Aberration Test
• ■ Mammalian Cell Gene Mutation Test
• ■ Mammalian Cell Micronucleus Assay
• ■ Fluorescence in Situ Hybridization

In Vivo Genotoxicity Assays

• ■ Rodent Micronucleus Test
• ■ Unscheduled DNA Synthesis
• ■ Bone Marrow Chromosome Aberration
• ■ Gene Mutation Assay
• ■ Immunofluorescent Antikinetochore
• ■ Combined Comet/Micronucleus Assay
• ■ Mammalian Alkaline Comet Assay

We provide additional support and follow-up assays, beyond standard genetic screening and regulatory assays. Our team collaborate closely with other safety evaluation groups to enrich study results and we’re dedicated to maintaining integrity through supplementary services:

• ■ Formulation and analytical chemistry;
• ■ Pathology and bioanalysis;

The other way around, via evaluating genetic toxicology biomarkers and identifying mechanism of action, we can support and enhance other safety related studies.

Highlights

As a part of our preclinical solution portfolio, our solutions for genetic toxicology are used in over 50 countries. We ensure robust data in compliance with global regulatory guidelines so that it can be accepted internationally. Our data management solution will ensure accurate results and coded audit tracking files which can record and edit system settings and measure data automatically.

Based on in-depth applications knowledge and expertise, Creative Biolabs offers professional and responsive services. We are dedicated to building long term mutually beneficial relationships with our sponsors, which has been evidenced by our long-term record and customer recommendations. Please browse our comprehensive suite of toxicological solutions and contact us to learn how we can help you to deliver the results sooner.