We deliver high quality data combined with scientific expertise and innovation to accelerate the progress of your pipeline and to provide you with the answers to your most complex toxicological and product safety questions.
OECD SAFETY TESTING
Our expertise in the development of EDSP testing strategies as well as our unmatched access to dermal tissue enables us to deliver all your OECD safety testing.
Dermal assays we offer:
- Dermal Corrosion (OECD 431, Corrositex®/OECD 435)
- Dermal Irritation (SIT/OECD 439)
- Dermal Sensitization (DPRA/OECD 442C, KeratinoSensTM/OECD 442D, U-Sens/OECD 442E, IL-8 Luc Assay/OECD 442E)
- Dermal Absorption (OECD 428, SCCS 1358/10)
Ocular assays offered:
- Ocular Irritation (EIT/OECD 492)
- Severe Ocular Irritation and Damage (STE Assay/OECD 491)
Endocrine disruption assays we offer:
- H295R Steroidogenesis Assay (OECD 456-T/E2, 13 Metabolite Panel)
EPITHELIAL IRRITATION TESTING
We combine established lung and vaginal models with custom endpoints to understand human-relevant toxicity.
The assays we offer include:
- Epithelial Irritation (Oral, Gingival, Vaginal)
- Epithelial Irritation and Toxicity (Bronchial/Tracheal, Lower Airway)
CYTOTOXICITY TESTING
Our carefully designed in vitro cytotoxicity tests and screening models help determine drug or chemical cell toxicity.
Understanding potential cytotoxic properties at relevant exposure concentrations can greatly improve the success of a New Chemical Entity in animal safety studies and human clinical trials.
The assays we offer include:
- Multiple End Point Toxicity Testing (endpoint panels custom designed for our clients)
- Membrane integrity
- MitoTox – Gluc/Gal, ATP, MTT, mitochondrial membrane potential
- Oxidative stress
- Inflammatory response
- Apoptosis/pyroptosis
The test models (2D and 3D organotypic) for the assays include:
- Intestine
- Liver
- Kidney
- Lung
- Multiple primary cells and cell lines
ADDITIONAL IN VITRO BIOCOMPATIBILITY & GENOTOXICITY TESTING
Evaluate medical device safety through our in vitro assay offerings, which meet International Organization for Standardization 10993 guidelines.
The biocompatibility and genotoxicity assays we offer include:
- Cytotoxicity (ISO 10993-5 MEM Elution)
- Skin Irritation (ISO 10993-23 3D Skin)
- Hemocompatibility (Hemolysis / Hemoglobin Denaturation / Clotting)
- Genotoxicity: Ames - 2 Strains or 5 strains (ISO 10993-3/ISO 10993-33 & OECD 471)
- Genotoxicity: Micronucleus Assay (ISO 10993-3/ISO 10993-33 & OECD 487)
ENDOCRINE DISRUPTION ASSAYS
We have a complete suite of assays to evaluate potential disruption of the endocrine system, including our 3D Thyroid Microtissue model for TDCs.
The assays we offer include:
- Estrogen Receptor Binding
- Androgen Receptor Binding
- Estrogen Receptor Transactivation
- Androgen Receptor Transactivation
- H295R Steroidogenesis Assay
- Aromatase Inhibition Assay
- Thyroid Hormone Disruption Testing with 3D Thyroid Microtissue Model
DMPK/ADMET
In vitro DMPK/ADMET assays are used to profile the pharmacokinetic properties of a drug candidate, including compound absorption, metabolic stability, protein binding, distribution, and liver-kidney drug-drug interactions. With drug development costs continuing to rise, this is an indispensable step to reduce failure rates.
The DMPK/ADMET assays we offer include:
- Stability in Plasma (Rat, Dog, NHP, Human)
- Intestinal and dermal absorption
- Plasma Protein Binding (Rat, Human)
- Microsomal Protein Binding
- Blood Partitioning (Rat, Human)
- Metabolic Stability (Rat, Human)
- Intrinsic Clearance (Rat, Human)
- CYP Induction (Rat, Human)
- CYP Inhibition (Human)
- Transporter Interactions (Human)
- Reaction Phenotyping (Rat, Human)
INTEGRATED MULTI-ORGAN MICROPHYSIOLOGICAL SYSTEM
Get superior, human-relevant data about the systemic impacts of a compound – without in vivo testing – through our novel multiple organ culture system.
Our MPS can help evaluate the following interactions:
- Intestine-Liver
- Intestine-Liver-Kidney
- Skin-Liver
- Skin-Liver-Kidney
- Lung-Liver
- Lung-Liver-Kidney
- Thyroid-Liver
TRUVIVO® SERVICE
Gain access to TruVivo, an all-human 2D+ hepatic system.
The assays we offer include:
- Intrinsic Clerance
- Thyroxine (T4) Metabolism related to CAR/PXR activation
- TruVivo + Kupffer Cells
- Hepatoxicity (DILI)
CUSTOMIZED PROJECTS
Our team of experts work closely with you to identify your unique testing needs to design a customized study plan and achieve your desired outcomes – with a focus on regulatory requirements.
