Facility and Compliance

Facility

1State-of-the-Art Non-clinical and Standalone Clinical Bioanalytical Laboratories

Intox’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.

2Our 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.

3Laboratory Capabilities

• Analytical Chemistry: Equipped with advanced technologies, our lab provides precise chemical analyses essential for safety assessments.

• Clinical Chemistry: Utilizing state-of-the-art autoanalyzers, this lab offers comprehensive clinical chemistry evaluations for diverse studies.

• Bioanalytical: Capable of handling both small and large molecules, our bioanalytical lab supports extensive pharmacokinetic and toxicokinetic studies.

• Histopathology: Expertly staffed and fully equipped, this lab conducts detailed tissue analysis and pathological examinations.

• DART (Developmental and Reproductive Toxicology): Well-equipped laboratories to perform necropsies and fetal examinations.

• Ecotoxicology and Environmental Fate: Focused on assessing the environmental impact of chemicals, with robust capabilities for comprehensive ecotoxicological studies.

• Genotoxicity: Dedicated to evaluating genetic toxicity, employing a range of in vitro and in vivo assays to detect potential mutagenic effects.

• Inhalation Toxicology: This facility houses state-of-the art Nose only exposure system procured from CH Technologies, USA and TSE, Germany.

4Support Facilities

• Dry and Wet Archives: Secure and compliant storage solutions for all study-related documents and samples.

• Test Item Control Office: Centralized management of test items, ensuring proper storage, handling and documentation.

• Formulation Preparation Labs: Specialized labs for the precise preparation and management of test formulations.

• Test item store, Dose formulation preparation laboratory, Archives for documents, test item samples, and specimens.

5Accreditations and Compliance

We proudly hold accreditations from renowned bodies, showcasing our commitment to quality and compliance:

• OECD GLP certification: Recognized since 2007 for our adherence to Good Laboratory Practice standards.

• CDSCO: Approval for performing Standalone Regulatory Clinical Bioanalysis

• DSIR: Department of Scientific and Industrial Research accreditation, affirming our research capabilities.

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.

Animal Ethics & Welfare (IAEC)

• 24-hour access to on-site attending veterinarians
• Approval of experimental protocols by the Institutional Animal Ethics Committee
• Adherence to national animal welfare guidelines (CCSEA) and global guidelines such as FELASA

Institutional Biosafety Committee (IBSC)

• DBT-registered IBSC to review, edit, and approve all studies involving biological materials
• These approvals ensure proper handling and disposal precautions recommended by Sponsors and Regulatory agencies

Routes of Administration

Oral (gavage & dietary), dermal, inhalation, parenteral (IV/SC/IM/ID)

• Other - Intranasal, ocular, intravitreal, otic, intra-articular;
• Implantation

Test Species

• Rodent/Small Animal: Rat (Wistar, Sprague Dawley), Mouse (Swiss albino, Balb C, C57BL6J, Tg.rasH2), Rabbit (New Zealand white), Guinea Pig (Duncan Hartley), Hamster (Syrian Golden)
• Non-rodent/Large Animals: Beagle Dog, Non-human Primates, and Minipigs (with partner CRO)
• Other: Chicken, Pigeon, Quail, Fish, Earthworm, Honeybee

Provantis® Software Solution

Provantis® is a modern, fully integrated Windows-based system used at Intox for real-time data capture, computation, and reporting for all toxicology studies.

SEND Capabilities

Intox provides data in SEND format for submission of preclinical data to regulatory agencies.

Analytical Chemistry Services

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.

• GLP Test Item characterization
• Method development and validation for analysis of test item concentration in dose formulations
• Testing stability and homogeneity of the test item in dose formulations – gavage, dietary, water (aquatic)
• 5-batch analysis including impurity profiling and synthesis of reference standards
• Phys-Chem for technical and diverse formulation types
• Residue studies
• Studies on behavior in water, soil and air; bioaccumulation
• Metabolism (in soil and animal)
• Regulatory assistance

Pathology Services

Intox was founded by eminent veterinary pathologists and understands its utmost importance.

1Clinical Pathology

• Labs are well-equipped with autoanalyzers and a trained team of technicians.
• Hematology analysis - Fully automated five-part veterinary specific
• Biochemistry analysis - Fully automated
• Coagulation parameters
• Urine analysis
• BALF analysis
• Hormone analysis - Thyroid, Reproductive
• Sperm assessment analysis using CASA software
• Quantitative Bone Marrow Evaluation

2Histopathology

Intox'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, Intox has a network of peer-review pathologists.

3Quality control

• Necropsy procedures - General, DART, and Inhalation studies
• Histology procedures & histopathology evaluation
• Immunohistochemistry (IHC)

Regulatory Guidelines Compliance