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
  • 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)
  • 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
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