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.
Aragen supports a wide panel of in vitro toxicology assays conducted under GLP guidelines to minimize animal use and 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.
Endocrine Disruption Screening
Toxicity Testing Platforms
Toxicity Testing Technologies
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. 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 the 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.
Exploratory Toxicity Studies in Rodents
Histopathology and clinical pathology routinely provide supporting validations for efficacy studies in Oncology, Cardiovascular and Metabolic Diseases, Inflammation, Pain and Toxicology. Our laboratories are managed by a dedicated pathologist and a veterinarian.
Bioanalytical data is essential and integral to the safety evaluation of new drugs. Our regulatory bioanalysis laboratory supports nonclinical pharmacokinetic and toxicokinetic safety studies for small and large molecules that are part of an IND, NDA or ANDA application. Laboratory instruments (HPLC, LC-MS/MS with Q-trap and Ion Chromatography) are operated in accordance with quality systems established as per the latest GxP guidelines. We handle a wide range of small and large molecules following various extraction procedures such as protein precipitation, liquid-liquid extraction and solid phase extraction.
Regulatory bioanalysis consists of pre-study validation, in-study validation, and documentation as per the ICH and USFDA regulatory requirements. Bioanalytical method validation consists of parameters such as selectivity, sensitivity, accuracy, precision, reproducibility, and stability. The laboratory has a dedicated sample management department with a sample custodian. Bioanalytical data storage is on dedicated servers with 24 hour backup and data transfer is end-to-end encrypted. Our team consists of scientists with PhDs and postgraduates in pharmaceutical analysis, headed by a test facility manager (TFM), study-specific principal investigators, and study personnel.