1. State-of-the-Art Non-clinical and Standalone Clinical Bioanalytical Laboratories
Aragen BioSafety Solutions’s state-of-the-art preclinical research facilities, spanning over 50,000 square feet on a 5-acre campus in Pune, India, provide an ideal environment for comprehensive safety testing in rodent and non-rodent species, as well as bioanalysis to support non-clinical and clinical samples. We conduct over 1,200 safety studies annually, offering a full range of in vivo and in vitro GLP and non-GLP safety assessments for your drug substances, vaccine candidates, crop protection agents, industrial and speciality chemicals. Our facilities are equipped to support toxicology, safety pharmacology, genotoxicity, ecotoxicology, and complete analytical testing, all within the campus.
2. Our Vivarium
Our facilities feature a state-of-the-art, two-floor vivarium with 50 rooms, tailored for various species to ensure animal welfare and research integrity. Environmental conditions are meticulously controlled and monitored through a centralized Environmental Monitoring System (EMS). One section of the vivarium is BSL-2 compliant, facilitating experiments with laboratory animals infected with agents related to human diseases, such as Mycobacterium, Streptococcus pneumoniae, and Salmonella choleraesuis.
The vivarium holds AAALAC accreditation and CCSEA approval.
3. Laboratory Capabilities
Equipped with advanced technologies, our lab provides precise chemical analyses essential for safety assessments.
Utilizing state-of-the-art autoanalyzers, this lab offers comprehensive clinical chemistry evaluations for diverse studies.
Capable of handling both small and large molecules, our bioanalytical lab supports extensive pharmacokinetic and toxicokinetic studies.
Expertly staffed and fully equipped, this lab conducts detailed tissue analysis and pathological examinations.
Well-equipped laboratories to perform necropsies and fetal examinations.
Focused on assessing the environmental impact of chemicals, with robust capabilities for comprehensive ecotoxicological studies.
Dedicated to evaluating genetic toxicity, employing a range of in vitro and in vivo assays to detect potential mutagenic effects.
This facility houses state-of-the-art nose-only exposure systems procured from CH Technologies, USA and TSE, Germany.
We have a proven track record of successful data submission to global regulatory agencies, including US-FDA, US-EPA, Canada, European Union, UK, Brazil, Argentina, Japan, India, Australia, and China.
Oral (gavage & dietary), dermal, inhalation, parenteral (IV/SC/IM/ID)
Provantis® is a modern, fully integrated Windows-based system used at Aragen BioSafety Solutions for real-time data capture, computation, and reporting for all toxicology studies.
Aragen BioSafety Solutions provides data in SEND format for submission of preclinical data to regulatory agencies.
Our analytical labs are equipped with advanced analytical tools to conduct method development and validation of various non-clinical formulations and characterization studies on crop protection and industrial chemicals.
Aragen BioSafety Solutions was founded by eminent veterinary pathologists and understands its utmost importance.
1. Clinical Pathology
2. Histopathology
Aragen BioSafety Solutions’s pathology team includes board-certified pathologists (ACVP and DIBTP) and a team of technicians. Labs are equipped with automated equipment to process the tissues and perform necropsies, histopathology evaluation, and peer-review. In addition to internal expertise, Aragen BioSafety Solutions has a network of peer-review pathologists.
3. Quality control
