Pharma-Biotech

Quick overview of Pharma-Biotech services we can provide :

• Toxicity Studies

  In vivo Toxicity studies

  • As per various OECD, Schedule Y and other regulatory guidelines
  • Reproductive Toxicity
  • Carcinogenicity

  • Acute-to-Chronic Toxicity
  • Reproductive Toxicity
  • Species: Mice, Rats, Rabbits, Dogs, Minipigs, Guinea Pigs

  Genotoxicity/ Mutagenicity

  • In vitro Micronucleus Test
  • In vivo Micronucleus Test
  • Cell gene Mutation Assay
  • Mouse Lymphoma Assay
  • As per various OECD, Schedule Y and other regulatory guidelines

  • Bacterial Reverse Mutation Test (Ames test)
  • In vitro Chromosomal Aberration Test
  • In vivo Chromosomal Aberration Test
  • Different cell lines for in vitro tests
  • Species for In vivo test: Mice, Rats
• Efficacy Studies

  Therapeutic areas

  • Oncology
  • GIT activity
  • CNS activity
  • Surgically or Chemically-induced animal models

  • Pain and Inflammation
  • Metabolic Disorders
  • Cardiovascular disorders
  • Ophthalmic diseases

  Species

  • Mice, Rats, Guinea pigs, Rabbits, Dogs, Minipigs, Sheep, Goat
• In vitro DMPK

  In vitro Permeability and P-gp Substrate Assessment

  • MDR1-MDCK cells

  • CACO2 cells

  Metabolism

  • Cytochrome P450 Inhibition
  • Cytochrome P450 Induction
  • Metabolite identification

  • Microsomal Binding (Mice, Rat, Dog, Human)
  • Microsomal stability (Mice, Rat, Dog, Human)
  • Hepatocyte stability (Mice, Rat, Dog, Human)

  Plasma Protein Binding

  Plasma/Whole Blood Stability

  Blood-to-Plasma Ratio

• In vivo Pharmacokinetics

  Pharmacokinetic Model

  • Absorption study
  • Excretion study

  • Tissue Distribution study
  • Blood Brain Barrier study

  Dosing and Sample Collection

  • Cannulated/ Non-cannulated animals
  • Single / Multiple dose
  • Different Routes of administration
  • Species: Mice, Rats, Guinea pigs, Rabbits, Dogs, Minipigs, Goat, Sheep

  • Specialized routes: Intranasal, Ophthalmic, Inhalation, Intratracheal, Depots
  • Ethically approved blood collection techniques
  • Various biological fluids and tissue sample collection

  Pharmacokinetic parameters evaluation using WinNonlin software

• Bioanalysis

  Bioanalytical Method Development & Validation

  • Fit-for-research Method
  • Small and Large molecules

  • Partial/Complete method validation
  • Instruments: HPLC and LC-MS/MS

  Biological fluid analysis

  Tissue homogenization and analysis

• Biological Formulations/ Biosimilars/ Vaccine candidates

  • Toxicity studies
  • Experience in handling wide range of Biological products
  • Analysis using ELISA, LC-MS/MS
  • Immunization studies

  • Pharmacopoeial Bioassays for Biosimilars
  • Clinically relevant Dosing Regimen
  • Immunization studies
  • In vivo Efficacy studies
• Standalone Services

  • IND-enabling Studies
  • Histopathological services
  • Bioanalytical services
  • Archival Services
  • Pharmacokinetic parameters evaluation using WinNonlin software

  • Polyclonal/Monoclonal Antibody generation in various species
  • Hematology and Clinical Biochemistry Analysis
  • Providing various Tissues and Biological fluids including Plasma/Serum