We offer a combination of in vitro and in vivo toxicology assays coupled with GLP bioanalysis to help de-risk drug candidates and enable critical and timely go/no-go pipeline decisions.

In Vitro Toxicology – Toxvit™

Aragen supports a wide panel of in vitro toxicology assays conducted under GLP guidelines to minimize animal use and to provide a cost effective way for early assessment of compound safety. With a suite of modern, reliable and validated testing technologies and protocols, combined with large scale operations with high-throughput equipment, we can reduce testing times and control costs. ToxvitTM enables decisions on human relevant dose levels and robust mechanistic data for the effective translations of assay results.

In Vitro Toxicity Solutions

Multi-Parametric Cytotoxicity

  • IC50 determination
  • Cell loss/death (fluorescent imaging)
  • Nuclear size and morphology (fluorescent imaging)
  • Cell membrane permeability (fluorescent imaging)
  • ~50 different cell lines of human origin available for cytotoxicity testing

Genetic Toxicity

  • AMES MPF assay using Xenometrix AG – ANIARA microplate kit method (OECD 471)
  • In vitro micronucleus assay using CHO, CHL, A549 cell lines and human PBMCs including cytotoxicity assessment on high content screening (HCS) platform (OECD 487)
  • In vitro chromosomal aberration assay using CHO cell line and human PBMCs including cytotoxicity assessment (OECD 473)
  • Mammalian cell gene mutation assay: MLA (L5178YTk+/- cell line) and HPRT (CHO-K1 cell line) mutations (OECD 490/476)
  • In vitro comet assay using PBMC, CHO, CHL test systems on HCS platform
  • H2AX double strand DNA damage response assay using A549, HepG2 and BEAS-2B cell lines on HCS platform

Dermal Toxicity

  • In vitro irritation using 3D reconstructed human epidermis models (OECD 439)
  • In vitro skin corrosion using 3D reconstructed human epidermis models (OECD 431)
  • Phototoxicity assay using BALB/c-3T3 cells
  • Skin sensitization assay using KeratinoSens cell line (OECD 442D)
  • Skin sensitization by directing peptide reactivity assay (OECD 442C)

Ocular Toxicity

  • Short term exposure assay using corneal epithelial cells (Statens Seruminstitut Rabbit Cornea SIRC cell line) (OECD 491)
  • EpiOcular™ eye irritation assay using 3D reconstructed human corneal epithelium tissue model (OECD 492)

Hepatotoxicity Panel

  • Using HepG2, HUH7, Hep3B cell lines and human iPSC HepRG spheroid cultures
  • Drug-induced phospholipidosis and steatosis
  • Lysosomal trapping (lysosomotropism)
  • Cholestasis
  • Mitochondrial permeability transition

Cardio Toxicity

  • hERG safety screening using Invitrogen’s Predictor™ hERG fluorescence polarization assay kit
  • 3D microtissue-based cardiotoxicity assay using human iPSC – CM (cardiomyocytes) spheroid cultures

Mitochondrial Toxicity

  • Mitochondrial (Glu/Gal) assay in glucose and galactose supplemented media
  • Mitochondrial membrane potential and cytochrome release

Neuro Toxicity

  • Developmental neurotoxicity
  • Neurite outgrowth
  • Synaptogenesis assay

Endocrine Disruption Screening

  • Estrogen receptor and androgen receptor binding assays, using polar screen, human full-length ER (alpha/beta) competitor assay and polar green rat androgen receptor competitor assay
  • Fluorescence polarization assay kits using ligand binding assays for ER and AR from rat membrane preparations (OPPTS/OCSPP 890.1250, OPPTS/OCSPP 890.1150)
  • Steroidogenesis assay using H295R cell line with testosterone parameter assay kit and estradiol parameter assay kit (R&D systems) (OECD 456)
  • Aromatase assay: (OPPTS/OCSPP 890.1200)

Toxicogenomic Profiling

  • Toxicological gene regulation studies through relative and quantitative expression of metabolic and toxicological pathway regulatory biomarkers using RT PCR and NGS platforms

 Toxicity Testing Platforms

  • High content imaging (thermo scientific cell insight) CX7 platform
  • Multimode reader – Perkin Elmer Envision 2104 platform
  • Flow cytometry – BD FACS verse platform
  • Agilent platform for HPLC
  • RT PCR – Applied Biosystems QuantStudio 6Flex platform
  • Next generation sequencing (NGS) – Illumina platform

Toxicity Testing Technologies 

  • Primary cell culture technology
  • Pluripotent stem cell technology (PSC)
  • 3D microtissue culture technology

In Vivo Toxicology – Non GLP

Aragen performs exploratory non-GLP in vivo toxicology studies for the safety evaluation of pharmaceutical, biopharmaceutical, agrochemical, veterinary and consumer products. We help our clients characterize the extent and consequences of injury that an NCE/NBE could produce at varied dosages to understand the risk/benefit equation of a drug candidate. Our studies can be modified to accommodate varying customer needs.

Our scientific team has an extensive track record in the design, performance and interpretation of a range of preclinical investigative and mechanistic toxicology programs. All our studies are conducted with protocols approved by the Institutional Animal Ethics Committee (IAEC) under the supervision of trained veterinarians/pathologists. Toxicology studies are supported by in-house histopathology and clinical pathology.

Choosing a lead compound from a pool of candidates does not have to be time consuming or expensive. If you are at the early candidate selection stage of a discovery program, the efficient use of exploratory toxicology testing can be the simple, cost effective answer to a challenging decision.

Safety & Toxicology Evaluation

CNS Safety

  • Tail suspension testing in mice
  • Spontaneous locomotor activity measurement in rats
  • Rotorod testing in rats and mice

Exploratory Toxicity Studies in Rodents

  • Acute toxicity/maximum tolerated dose (MTD)
  • Repeat dose 7-90 days toxicity studies
  • Toxicokinetic studies (TK)
  • In-house histopathology and clinical pathology
Clinical Pathology & Histopathology

Histopathology and clinical pathology routinely provide supporting validations for efficacy studies in Oncology, Cardiovascular and Metabolic Diseases, Inflammation, Pain and Toxicology. Our labs are managed by a dedicated pathologist and a veterinarian.


  • Hematology analyzer
  • Clinical chemistry analyzer
  • Electrolyte analyzer
  • Urine analyzer
  • Blood gas analyzer


  • Automated tissue processor
  • Tissue embedding system
  • Cooling system
  • Rotatory microtome
  • Cryostat
  • Automatic multistainer
  • Semi-automated bright and fluorescence microscopes
  • Image analysis software