Toxicology

Gentury is committed to providing in vitro and in vivo toxicology services which support the early drug discovery and lead selection/optimization. In continuation of plate-based efficacy services, Gentury provides rapid and valuable safety evaluation to define the potential of new compounds in your pipeline. Client’s compounds will be quickly analyzed for the safety profile in early stage through most our in vitro HTS in vitro toxicology assay as low as 10ul of 10mM.(eg, ~10ul of 10 mM compound can be used for most following in vitro toxicology assays). For further evaluation of compound toxicity, in vivo toxicology study can be initiated and performed in rodents soon in our new SFP level IACUC animal facility.
 

In vitro toxicology studies
 
We provide robust and rapid in vitro toxicity screening approaches to identify compound liabilities and its STR (structure toxicity relationship) in order to further optimize NCE in an early drug discovery stage. Our fast turnaround results from multiple assays and dose-response profiles help our clients to define the potential toxicity of compounds and assists our clients to select lead compounds with higher probability of success and faster speed. Most of our assays are of high throughput system (eg. 384 plate format) that requires small amounts of tested compound with fast data turnaround (eg. one week).
 
Genotoxicity
 
Ames Test
Micronucleus test (manual / automatic)
HTS method available
 
Cardiac Toxicity
 
hERGs patch clamp
hERGs binding assay
 HTS method available
 
Hepatotoxicity
 
Hepatocyte cell viability
Steatosis and phospholipidosis
 HTS method available
Enzyme induction
 
Mitochondrial toxicity
 
Fluorescence-based oxygen consumption assay
 HTS method available
Membrane potential transition (MPT)
 HTS method available
 
Cytotoxicity
 
ATP content assay
 HTS method available
LDH assay
 HTS method available
MTT assay
 HTS method available
 
Testing will be performed on HepG2 cell line, hepatocyte, astrocytes, neuron cells and other cell lines.
 
Drug-drug interaction
 
Human CYP3A4 induction cell based assay
 HTS method available
Human CYP1A induction cell based assay
 HTS method available
P-gp inhibition cell based assay
 HTS method available
 
In vivo toxicology studies
 
Gentury in vivo toxicology services provide the flexible access to rodents and non-rodent animal species with a variety of administration routes to characterize adverse effects, determine severity and reversibility, to establish a dose-response relationship, to assist in dose selection for clinical trials and to predict genotoxicity. Clinical observation, histopathology, gross pathology, clinical chemistry, hematology and urinalysis will be evaluated in the following study upon your request. Gentury owns a new SPF level. AAALAC-compliant animal facility for rodent studies. Non-rodent animal species can be tested in off-site facilities.
 

Local tolerance test
Dose-range-finding study
Acute toxicity study
Repeat dose study
NOAEL (no observable adverse effect level) determination
In vivo micronucleus testing
Toxicokinetics
 
 
In vivo mouse bone marrow micronucleus testing