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Brochure

Genetic and Alternative Toxicity Testing for Compound Screening, Derisking and Selection

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Aragen has almost three decades of experience testing a wide variety of molecules including pharmaceuticals, agrochemicals and industrial chemicals.
 
Genotoxicity and mutagenicity both involve damage to genetic material. Genotoxicity refers to the capacity for a substance to damage genetic information within cells. Mutagenicity refers to the capacity for a substance to cause permanent, transmissible changes to genetic structure or amount of genetic material.
 
Testing at Aragen will identify genotoxicity as well as mutagenicity potential of your test article. We will provide reliable, efficient data as you screen libraries of multiple compounds for derisking your portfolio and candidate selection. Additionally we will also support your OECD safety and toxicology testing as you move towards regulatory filing.
Our toxicology and safety testing protocols are designed by technical experts in their respective fields and validated by regulatory bodies. It is important to note that study design will vary based on the type of molecule, its intended application and regulatory requirements. It is crucial to consult with toxicology and regulatory experts to create an appropriately tailored testing strategy.

The Aragen Advantage:

  • OECD GLP compliant and AAALAC accredited facilities
  • DABT and ACVP board-certified toxicologists and pathologists
  • Complete GLP safety and toxicology programs for many compound types
  • Bioanalytical, pathology and histopathology performed onsite
  • Comprehensive bioanalytical support from early method development to clinical bioanalysis
  • Over 16,000 GLP studies performed to date

Aragen’s portfolio of Genotoxicity and Alternative Toxicity Testing:

S. No.Name of the testTest guidelineTest systemTAT
1In Silico tools to predict genotoxicityVega So wareICHM7Mutagenicity (Ames test) CONSENSUS
model 1.0.2
Mutagenicity (Ames test) model
(CAESAR) 2.1.13, (SarPy/IRFMN) 1.0.7,
(ISS) 1.0.2, (KNN/Read-Across) 1.0.0		1 week
2Mini Ames- Non GLP–Salmonella typhimurium TA98, TA100,
TA1535, TA1537 and E. coli WP2 uvrA,
E. coli WP2 [pKM101]		1 week
3Bacterial reverse mutation test (Ames
Test		OECD 471Salmonella typhimurium TA97a, TA98,
TA100, TA102 and TA1535		1 month
4In Vitro Chromosomal Aberration TestOECD 473Human Peripheral Blood
Lymphocytes		1.5 months
5In Vitro Mammalian Cell Gene Mutation
Tests Using Thymidine Kinase Gene		OECD 490L5178Y/Tk+/–3.7.2C mouse
lymphoma cell line		1 month
6In Vitro Mammalian Cell Gene Mutation
Tests Using Hprt or Xprt Genes		OECD 476CHO-K1 Cell Line1 month
7In Vitro Micronucleus Test
(Micronuclei enumeration using
automated FACS technique for rapid TAT)		OECD 487Human Peripheral Blood
Lymphocytes,
TK6 Human Lymphoblastoid Cell line		2 weeks
8In Vitro Skin Corrosion: Transcutaneous
Electrical Resistance Test Method (TER)		OECD 430Rat (Rattus norvegicus)2 weeks
9In vitro phototoxicityOECD 432BALB/c 3T3, clone A31, (ATCC) CCL163
Mouse Fibroblast cell line		2 weeks
10Mammalian Erythrocyte Micronucleus
Test		OECD 474Mice (Swiss albino)1 month
11In Vivo Chromosomal Aberration TestOECD 475Mice (Swiss albino)1.5 months
12Short Time Exposure In Vitro Test Method
for Identifying
i) Chemicals Inducing Serious Eye
Damage and
ii) Chemicals Not Requiring Classification
for Eye Irritation or Serious Eye Damage		OECD 491Statens Serum Institue Rabbit Cornea
Cell Line (SIRC)		3 weeks
13In Vitro Skin Irritation: Reconstructed
Human Epidermis Test Method,		OECD 439Reconstructed Human Epidermis2 weeks
14Biological evaluation of medical devices –
Tests for In Vitro cytotoxicity		ISO10993-5,12L929 Mouse Fibroblast Cell line2 weeks

Aragen Life Sciences is a leading contract research, development, and manufacturing organization offerings end-to-end integrated and standalone solutions for pharmaceutical, biotechnology, crop protection and industrial chemical industries. To learn more about Aragen’s services or to discuss your safety assessment program with one of our experts, write to us at bd@aragen.com.