CEFT - Services
Test system
Rats - Wistar, Sprague Dawley
Mice - Swiss albino, Balb/C, C-57, Athymic
Rabbits - New Zealand White
Guinea pigs - Dunkin Hartley
Fish - Zebrafish
Bacterial strains - Salmonella typhymurium
Route of administration
Oral, dermal and Parental routes (iv, im, sc, ip...etc)
Test item categories
- Pharmaceuticals
- Agrochemicals / Pesticides
- Nutraceuticals
- Cosmetics
- Herbal based / Alternative medicines
- Medical devices
Toxicology services
- Acute / Single Dose Toxicity
- Maximum Tolerable dose and Dose range Findings
- Local Toxicity studies- Skin / Eye / mucus membrane,
- Skin sensitization- Guinea pig (GPMT)
- Sub-Acute / Sub-Chronic toxicity - Repeat Dose 7/14/28/90 day
- Chronic Toxicity - Repeat Dose 180 day/ one year
- Carcinogenicity
- Reproduction & developmental toxicity studies - fertility, teratology, multi-generation
Genetic Toxicity services (In-vitro and in-vivo)
- Ames reverse-mutation assay
- Micronucleus study in rodents
- Chromosomal aberration test
- Mouse lymphoma assay
- Comet assay
Biocompatibility Testing (Medical device)
- In Vitro Cytotoxicity (ISO 10993-5)
- Quantitive (Colony Forming Assay)
- Qualitative methods (Elution Test, Agar Diffusion Test)
- Skin Sensitization, Maximization Method or Closed Patch Test (ISO 10993-10):
- Intracutaneous Reactivity Test (USP <88>/ISO 10993-10)
- Primary Skin Irritation (ISO 10993-10)
- Acute Ocular Irritation
- Mucosal Irritation Testing: (ISO 10993-10)
- Systemic Injection Test (USP <88>/ISO 10993-11)
- Implantation Test – 1, 4, 12, 26, 52 Weeks (USP <88>/ISO 10993-6)
- Hemocompatibility Testing
- ASTM Hemolysis – Direct contact and extract method
- Complement Activation – C3a & SC5b-9 Assays
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Genotoxicity Testing (ISO 10993-3)
- ISO in-vitro mouse Lymphoma with extended treatment (2 extracts)
- ISO in-vivo mouse Micronucleus Assay (2 extracts)
- ISO bacterial mutagenicity – Ames Assay (5 salmonella strains & 1 e. coli strain – 2 extracts)
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Compendial Testing
- Abnormal Toxicity- European Pharmacopeia standard for assessment of biological.
- Pyrogen Test (USP <151>)
- Bacterial Endotoxin (LAL) Test (USP<85>)
- Bacterial Endotoxin (BET)Test Validation (USP <85>)
- Biological Reactivity Tests, in vitro (USP<87>)
- Safety Test, General (USP <88>)- transfusion and infusion assembly extracts.
- Safety Test, Biologics (USP <88>) Test battery required by the FDA Regulations for lot validation of licensed biological products.
- Systemic Injection Test (USP <88>/ISO 10993-11)
- Biological Reactivity Tests, in vivo (USP<88>) {Class Plastics Testing}- to evaluate the biological response to plastics for use in medical devices, implants, containers, and base materials.
Pharmacokinetics and Toxicokinetics
- Single bolus - Oral and intravenous route of administration
Bio-analytical Assays (Large Molecule)
- Method development, validation and sample analysis as per EMA/FDA guidelines
Critical reagent production
- Regular and Cascade immunization against Proteins, Peptides, Mixture of proteins, Fab fragments, Characterization by ELISA, Western, IHC, IF and Purification: Protein A/G, Affinity in Rat/Mouse, Rabbit, Guinea Pig, Goats
- In vivo bioidentity testing of proteins and Peptides
- Anti-sera (polyclonal/monoclonal) - Rat, Mice, Rabbit Alternative to animal models
Alternative to animal models
- Skin corrosion - in vitro model (study specific)
- Ocular irritation - in vitro model (study specific)
- Oral irritation - in vitro model (study specific)
Pharmacological services
CEFT have well-established and validated in vivo disease / screening models:
- Anxiety models (elevated plus maze, hole board, 2. Stress induced Hyperthermia)
- Cerebral stroke (middle cerebral artery occlusion, 4 vessel occlusion)
- Depression (Chemical, behavioural CUMS, Stress induced LTD in Rat Hippocampus)
- Epilepsy (pentylenetetrazole, picrotoxin, strychnine, Bicuculline, Beta- Carbolines, Guanidine etc)
- Parkinsonism (MPTP model, 6-OHDA Unilateral Intrastriatal Lesion Model)
- Huntington's disease (3-nitropropionic acid)
- Alzheimer's disease (Scopolamine-induced amnesia, Aß peptides infusion)
- Gastric ulcer (Shay model, acetic acid/ ethanol induced, drugs induced)
- Hepatic diseases (Paracetamol, anti-TB drugs, CCl4, Thioacetamide, Galactosamine, Azathioprine , concanavillin, Alcoholic / Non-Alcoholic Steatohepatitis)
- Diabetes (alloxan, streptozotocin, high calorie / diet model, Dithizone, G-thioglucose genetic models)
- Hyperlipidemia and obesity (triton WR 1339, high fat diet model)
- Hypertension (2K/1C - renovascular, DOCA salt induced, Goldblatt, Angiotensin-II etc)
- Cardicac toxicity (Doxorubicin, Anthramycin & Surgical models)
- Myocardial infarction (isoproterenol model)
- Immunology (Cell mediated and humoral mediated)
- Inflammatory models (carrageenan, cotton pellet granuloma etc)
- Rheumatoid arthritis (FCA model)
- Tendonitis (Collagenase & Carrageenan)
- Nootropics (radial arm maze, passive avoidance, transfer latency)
- Pain models (formalin and acetic acid, vincristine, cisplatin, oxaliplatin, paclitaxel etc)
- Stress induced LTD (Long Term Depression) in Hippocampus in rat
- Post Surgical Pain model of mechanical hyperalgesia and allodynia in rat
- Cancer Xenograft model
Serum /plasma
- Blood will be collected from untreated rats under suitable anesthesia. Details of anesthesia will be mentioned on dispatch document.
- CEFT scientists will do the procedures till plasma separation following all standard practices. Plasma/ serum will be stored in -200C till samples shall be collected by sponsor from CEFT
Biochemical and Molecular techniques
- Estimation of tissue / plasma anti-oxidant, membrane markers, mitochondrial enzymes, Inflammatory biomarkers and apoptotic markers, Hormones etc
- Isolation and protein / Gene mRNA Expression of proteins markers.
- Single target protein or co-expression of multiple proteins cytokines expression, oxidative stress markers expression, TUNNEL assay, double immunofluorescence etc
- Cytotoxicity using Human / Animal Cell Lines and evaluation of target protein(s)
Pathology and Immunohistochemistry
- Necropsy, Fixing, trimming, embedding, sectioning and staining tissues.
- Special staining or immunohistochemistry, immunocytochemistry, protein co-localisation
- Histopathology Slide reading by Veterinary Pathologists trained for toxicologic / experimental Pathology