Transforming lives by accelerating discovery







  •    Discovery and Development

  •    IND enabling preclinical studies

  •    GLP    •  AAALAC
  •    CPCSEA   •  DSIRS





Molecular Biology

Gene synthesis and cloning

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  • Tailor made vectors through cloning of cDNA, promoter or genomic DNA into any vector for the desired downstream application
  • Reporter systems, site-directed mutagenesis, cDNA and genomic DNA libraries

Expression analysis

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  • mRNA, miRNA and protein isolation from various cell types and tissue samples
  • Quantitative analysis of mRNA and miRNA by real time RT-PCR and protein expression analysis performed using Western blotting or ELISA

Protein expression and production

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    Bacterial
  • Comprehensive services in cloning, expression and purification of peptides and proteins
  • Purification of therapeutic proteins, growth hormones, industrial enzymes and viral proteins in bacteria
  • Yeast
  • Bio-process optimization in various yeast expression systems - Saccharomyces cerevisiae, Pichia pastoris
  • Mammalian
  • Transient expression of proteins using plasmid transfections
  • Stable expression in engineered cell lines using lentiviral vectors
  • High expression levels of heterologous proteins in CHO, Sp2/0 and HEK cell lines

Toxicology

Genetic Toxicology

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  • Ames test
  • Chromosomal aberration test (In vitro & In vivo )
  • Micronucleus test (In vitro & In vivo )
  • Mouse Lymphoma assay

In vivo toxicology services

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  • Acute (Six Pack) studies
  • Acute Toxicity
  • Maximum Tolerated Dose (MTD)
  • Dose Range Finding study
  • Repeat dose (7 - 90 day) Toxicity studies
  • Chronic Toxicity
  • Developmental and Reproductive Toxicology (DART) Studies
  • Carcinogenicity
  • Eye Irritation Test
  • Skin Irritation Test
  • Skin sensitization (LLNA)
  • Eco toxicology services – Studies on Daphnia, fish, earthworm, honeybee, algae

In vitro toxicology

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  • Ames test
  • hERG binding Assay
  • Hepatotoxicity
  • Cytotoxicity
  • Skin Irritation test Episkin
  • Skin corrosion test
  • 3T3 Neutral Red Uptake assay
  • In vitro Mammalian Cell Gene Mutation test: L5178YTK+/- Mouse lymphoma

Bio-Analytical Development and Validation

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  • Pre-formulation development for preclinical studies
  • Method development and validation (Formulation & Toxicokinetics)
  • Toxicokinetics analysis
  • Immunogenicity
  • Dose confirmation analysis
  • Residue Analysis

Other services

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  • Phospholipidosis and Steatosis Assay
  • Lysosomotropism
  • Hemolysis assay
  • Transdermal Permeability Testing
  • Phototoxicity Testing
  • Colony formation cytotoxicity test
  • MTT cytotoxicity test
  • Filter Diffusion test
  • Agar Diffusion test
  • Allergenicity Studies

Microbiology

In vitro microbiology

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    Anti-infective screening
  • Microbial characterization (antibiotic resistance screening)
  • Antimicrobial evaluation of compounds by Broth dilution/Micro broth/Agar dilution/Agar well diffusion/disc diffusion method
  • MIC determination for antibacterial and antifungal compounds, MIC50, MIC90, MIC with variable elements (serum, albumin, inoculum, temperature effect)
  • Kill kinetics (Time Kill), Post-antibiotic effect (PAE)
  • Mutation prevention concentration (MPC) and frequency determination
  • In vitro Resistance development
  • Microbial biofilm susceptibility
  • Drug combination study (FIC index, synergism/antagonism /indifference /additive effect)
  • Efflux pump inhibitor screen (ethidium bromide accumulation)
  • Beta lactamase inhibitor screening
  • Hemolytic activity
  • S-35 methionine incorporation (for de novo protein synthesis)
  • PK-PD correlation
  • Bacterial reverse mutation test (Ames test)

  • Cosmetics/Personal care products evaluation
  • Preservative efficacy test (PET)/ Preservative Challenge Testing
    • ISO-11930-2012 Cosmetics
    • USP39 – (51) Antimicrobial effectiveness Testing
  • Antimicrobial activity
    • ASTM: E 2315 – 03 Assessment of Antimicrobial Activity Using a Time-Kill Procedure
    • BS EN 1650:2008+A1:2013: Chemical disinfectants and antiseptics
  • BS EN 1276:2009: Quantitative suspension test for the evaluation of bactericidal activity
  • Sterility test /Total viable count (Product evaluation
  • Microbiological Examination
    • IS 14648: 2011 Microbiological Examination of Cosmetics and Cosmetic raw material

Bacteriophage

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  • Isolation of bacteriophages for specific strains
  • Characterization – Host range analysis with multiples strains/ One step Growth curve/Burst size/TEM analysis
  • Genomic sequence of phages
  • Stability studies for bacteriophage formulations
  • In vivo efficacy evaluation of bacteriophages
  • Available bacterial/fungal strains include multidrug-resistant (MDR) pathogens (ATCC/other)
    • Gram Positive strains
    • Gram Negative strains
    • Yeast & Molds
    • Anaerobes and facultative anaerobes

In vivo microbiology

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  • Bacterial peritonitis/ Systemic Infection Models/Outcome model – ED50 determination
  • Organ burden model
    • Thigh – Gram negative/ Gram positive
    • Lung
    • Vaginal
    • Skin/wound

In vivo Pharmacology

Oncology

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    Human xenograft tumor models in immune-compromised mice
  • Cell line derived xenograft models
  • Orthotopic tumor models
  • Metastasis and angiogenesis models
  • PK/PD correlation studies
  • Biomarker analysis in tumor tissue by IHC/ ELISA/WB/qRT-PCR
  • Flow cytometry analysis of tumor tissues

Immuno-oncology models

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  • Tumor models for Immuno-oncology- Syngeneic tumor models in immunocompetent mice
  • Tumor Models: EMT6, CT26, LLC-1, B16F10
  • Efficacy of checkpoint inhibitors, Anti-PD1 and Anti-CTLA4, CART-cell therapy
  • Tumor microenvironment studies by Flow Cytometry
  • Tumor infiltrating lymphocytes (TILs), Tumor associated macrophages
  • Cytokine evaluation in Tumors and Serum (IL-6, IP-10, IFNβ)
  • Efficacy evaluation combined with Tumor/Blood sampling for Pharmacokinetics, hematology, tumor histology, analysis of proliferation and apoptosis markers (p53, Ki67, TUNEL staining)

Panel of Tumor Models

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Origin Histotype Cell line
Human Prostate adenocarcinoma PC3, DU-145, VCaP
Breast Adenocarcinoma MDA-MB-231, MCF7, BT-474
Colorectal Adenocarcinoma HCT-116, HT-29
Ovarian Adenocarcinoma SK-OV-3, NIH:OVCAR-3
Lung Carcinoma (NSCLC) A549, NCI-H460, NCIH-1299, NCI-H187
Pancreatic epithelioid carcinoma PANC-1, MIA PaCa-2
Renal carcinoma 786-O, A498
Nasopharyngeal carcinoma FaDu, C666-1, HK1,
Glioblastoma U-87MG
Syngeneic
(Mouse)
Lewis lung carcinoma LLC-1
Melanoma B16F10, B16F0
Colon CT26
Breast EMT6


Inflammation models

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  • Inflammatory bowel disease (DSS induced colitis)
  • Carrageenan induced edema
  • LPS induced sepsis/cytokine release models
  • Atopic dermatitis model
  • Biomarker analysis
    • Inflammatory markers, cytokine analysis in plasma/tissue (TNF-α, IL-6, IL-1), Histopathology and IHC

Autoimmune disease models

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  • Rheumatoid Arthritis: Collagen/ Adjuvant-induced Arthritis (CIA) model in DBA1 mice/ Lewis Rats
  • Graft Vs. Host disease (GvHD): Allograft GvHD mouse model
  • Clinical endpoints: Kaplan-Meier survival analysis, Disease scoring, Histopathology, Cytokine analysis, Flow cytometry
  • Imiquimod induced psoriasis
  • Immunomodulatory studies: Ex vivo study in Mouse splenocytes

Metabolic diseases and Liver disease models

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  • Mouse/Rat models of diabetes and obesity
  • Genetic models of obesity/diabetes: db/db and ob/ob mice
  • Streptozotocin induced diabetes
  • High fat induced (HFD) induced diabetes and HFD induced obesity (DIO), dyslipidemia models
  • Glucose tolerance studies
  • Fatty Liver disease
  • CCL4 / Ethanol/ Drug induced hepatotoxicity models
  • Clinically relevant endpoint analysis by clinical chemistry, histology, ELISAs, qPCR.

Neuroscience disease models

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  • Multiple sclerosis: Experimental autoimmune encephalomyelitis (EAE)
  • Neurodegenerative disease
    • Amyotrophic lateral sclerosis (ALS) in transgenic SOD1G93A mice
  • Epilepsy models: Maximum Electroshock (MES) and Pentylenetetrazole (PTZ) induced seizures

Assay Biology

Enzymatic assays

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  • Anti-oxidants (ORAC/NORAC/SORAC/HORAC)
  • NAD/NADH
  • Nitric oxide synthesis
  • Cox and Lox
  • Prostaglandins
  • Kinase assays
  • Epoxide inhibition assays
  • Hydrolase inhibition assays
  • Reporter based NF-kb activation assay
  • HDAC assay
  • Caspase assay
  • Cathepsin inhibition assay
  • AMPK activation assay
  • Protease and DNase assay
  • Bead based removal of RNA from DNA sample
  • Immunomodulatory effects of ANDA molecules and small molecules

Expression and PTM assays

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  • mRNA expression using qRT-PCR
  • Protein expression through western blot analysis
  • AMPK activation assay through ELISA
  • Signal transduction assay through western blot analysis
  • Aβ-42 estimation
  • Cytokine, chemokine and growth factors through ELISA
  • Human APP through ELISA
  • Target modulation assay for Histone H3 and H4

Cell based assays

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  • Glucose uptake assay
  • Insulin secretion assay
  • Differentiation of pre-adipocyte to adipocyte
  • ROS assay
  • Fatty acid accumulation in HepG2 – Oil O red or Nile red staining
  • In vitro NASH model
  • In vitro Wilson disease model
  • Receptor binding assays
  • Migration and scratch assay
  • Tube formation (in vitro angiogenesis)
  • Cell proliferation and cytotoxicity assay
  • ATP synthesis assay
  • Mitochondrial aberration – JC-I staining
  • Mitotracker analysis
  • Phosphorylation
  • Early detection of cell apoptosis using Annexin V or caspase assay
  • PARP cleavage
  • DNA fragmentation
  • Cell cycle analysis (PI staining)
  • Cell cycle regulator expression study through qRT-PCR or western blot
  • Cell based reporter assays (promoter and signal transduction pathway analysis)

ADME/PK

In vitro DMPK

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  • Physicochemical properties
    • Thermokinetic and thermodynamic solubility (Multi-Screen HTS filter plates/ LC- MS/MS method)
    • Stability in buffer solutions, simulated gastric fluid and simulated intestinal fluid (Fasted and Fed), in plasma of different species like Mice, Rat, Dog, Monkey and Human
    • Log D, log P and pKa determination
    • Aqueous solubility and stability at different pH
  • Distribution
    • Plasma Protein binding determination by Ultrafiltration method and Equilibrium dialysis
    • Species: Mice, Rat, Dog, Monkey and Human
    • In vitro tissue binding, blood cell partitioning and microsomal binding
  • Absorption
    • PAMPA (Parallel Artificial Membrane Permeability Assay)
    • MDCK-wild type permeability
    • MDR1-MDCK permeability for P-gp interaction
    • Calcein AM assay for P-gp interaction and inhibition
    • Caco-2 permeability – unidirectional and bidirectional permeability
  • Metabolism
    • Metabolic stability in liver, intestinal microsomes, S9 fractions and hepatocytes
    • Metabolite identification (phase I and II) and characterization studies using LC- MS/MS
    • Species: mice, rat, dog, monkey and human

In vivo pharmacokinetics

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  • Types of PK studies
    • Single dose, multiple dose, cross over, cassette dose
    Routes
    • Oral, Intravenous, Subcutaneous, Intradermal, Intramuscular, Intraperitoneal, Per rectal
    Species
    • rat, mouse, hamsters, guinea pigs, rabbits
    Tissue distribution studies
    • Brain, liver, adipose, skin, muscle, spinal cord
    Pharmacokinetics studies in disease models
    • Cancer models e.g. tumor bearing animals
    • Diabetes models e.g. db / db mouse
    • Obesity models e.g. Ob/ob mouse, DIO mouse
    • Inflammation models e.g. IBD model, arthritis model
    • Tissue distribution in efficacy models and PK-PD correlation
    Pharmacokinetics data analysis
    • WinNonlin analysis
    • Parameters reported: Tmax , Cmax , AUClast , AUC∞, Cl, t1/2 , Vss, MRT and F%
    Bioanalytics
    • Method development and validation
    • Recovery and linearity studies
    • Development of analytical methods in Biological Matrix - plasma, serum, bone marrow, lymph node, urine, feces, bile and tissues
    • Sample analysis from both in vivo and in vitro studies

Facilities

Cell culture suites

  • •  Fluorescence imaging microscope
  • •  Multimode plate reader
  • •  Flow cytometer
  • •  Cell counter

Vivarium and Toxicology

  • •  Experiment rooms
  • •  Procedure rooms
  • •  Quarantine rooms
  • •  Surgery room
  • •  Necropsy room
  • •  Clinical chemistry and histopathology     facility

DMPK – Tox laboratory

  • •  LC-MS rooms
  • •  Sample storage rooms
  • •  Sample preparation rooms
  • •  Tissue culture lab
  • •  Test item storage room
  • •  Archival facility

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