Pharmaceuticals and Biopharmaceuticals

Pre-clinical Services for Pharmaceuticals in India

Vipragen has been serving this sector with quality services of Pharmaceutical and Vaccine testing for over a decade with a wide range of tests, specifically focused on Biologicals as per the global guidelines and as per International pharmacopeia (ICH, USP, IP) for global market approvals.  The types of studies offered for IND, ANDA, and NDA submissions/filings for Biotech and Pharma companies are listed here.

As an END-To-END service provider for Pharmaceutical Sector, Vipragen is capable of providing robust Discovery services with an experienced group of passionate Drug Discovery Scientists to take it towards an entire process of Development. Vipragen has developed various Animal models to validate specific disease models widely ranging from Metabolic lifestyle disorders, wound healing, inflammation, oncology and Anti-bacterial composites.

Pharmaceuticals and Biologics

Toxicology

Single Dose/MTD/6 Pack Studies

  • » Include full battery of animal tests used to evaluate acute systemic toxicity by three routes of exposure, skin and eye irritation/corrosion, and skin sensitization.
  • » Single Dose and MTD Range Finding Studies – Rat and Mice (OECD 423/425)
  • » Single Dose Dermal Toxicity Study in Rat (OECD 402)
  • » Single Dose Dermal Toxicity Study in Rabbit (OECD 402)
  • » Acute Inhalation Toxicity Study in Rat (OECD 403)
  • » Single Dose Oral Toxicity Study in Rat (OECD 423)
  • » Dermal Irritation/Corrosion Study in Rabbit (OECD 404)
  • » Ocular Irritation Study in Rabbit (OECD 405)
  • » Skin Sensitization Study – Guinea pig (OECD 406)

Repeated Dose Toxicity (Subacute, Sub chronic and Chronic)

  • » 14 Day Repeated Dose Toxicity Study in Rat and Mice with or without TK
  • » 28 Day Repeated Dose Toxicity in Rat and Mice with or without Recovery and TK (OECD 407, ICH M3 R2)
  • » 90 Day Repeated Dose Toxicity in Rat and Mice with or without Recovery and TK (OECD 408, ICH M3 R2)
  • » Chronic Toxicity (6 -12 Months) in Rat and Mice (OECD 452, ICH M3 R2)
  • » Combined Chronic Toxicity/Carcinogenicity Study in Rat and Mice (OECD 453)
  • » Carcinogenicity study in Rat and Mice (OECD 451, ICH M3 R2)

Genotoxicity

  • » Bacterial Reverse Mutation- AMES Test (OECD 471)
  • » In Vitro Mammalian Chromosomal Aberration Test (OECD 473)
  • » In Vivo Mouse Erythrocytes Micronucleus Test (OECD 474)
  • » In Vitro Micronucleus Test (OECD 487)
  • » In Vivo Chromosomal Aberration Test (OECD 475)
  • » In Vitro Skin Irritation- Reconstructed Human Epidermis Test (OECD 439)
  • » Local Lymph Node Assay (OECD 442 B)

Reproductive & Developmental Toxicity (DART)

  • » Male Fertility Study in Rat
  • » Juvenile (Neonatal) Toxicity Study in Rat and Mice
  • » Reproduction and Developmental Toxicity Screening Test in Rat (OECD 421)
  • » Combined Repeated Dose Toxicity Study with the Reproduction and Developmental Toxicity Screening Test in Rat (OECD 422)
  • » Prenatal Developmental Toxicity Study in Rat and Rabbits (OECD 414)
  • » Fertility and Early Embryonic Development Study in Rat and Mice -Segment 1 (ICH S5 R3)
  • » Teratogenicity/Embryo-Fetal Developmental Toxicity Study in Rat and Mice -Segment 2 (ICH S5 R3)
  • » Teratogenicity/Embryo-Fetal Developmental Toxicity Study in Rabbit- Segment 2 (ICH S5 R3)
  • » Pre & Postnatal Developmental Toxicity Study in Rat and Mice -Segment 3 (ICH S5 R3)

Safety Pharmacology Studies

  • » FOB / Irwin Test
  • » Telemetry
  • » Respiratory Assessment
  • » hERG Assay

Analytical Services

  • » Dose Formulation analysis (Stability, Homogeneity and nominal concentration)
  • » Method development and validation
  • » LC-MS/MS based Dose Formulation Analysis
  • » Physico-Chemical Properties and Five Batch Analysis
    1. » Solubility
    2. » Lipophilicity (LogD7.4)
    3. » Chemical stability (pH, plasma, body fluids)

Biologics and Biosimilar Testing

PCT Testing

  • » Vast experience in design and conducting biosimilar preclinical toxicity (PCT) studies for regulatory approval
  • » Selection of appropriate species (rodent and non-rodent)
  • » Dose levels and study design
  • » Report preparation and interpretation
  • » Presentation of study data in the regulatory approval meetings

Test for Batch Release

  • » Pyrogen test in rabbits
  • » Abnormal toxicity studies in mice & guinea pig
  • » Specific toxicity studies in guinea pig
  • » Mouse weight gain test
  • » In vivo potency test
  • » Accelerated In vivo potency test
  • » Mouse Neutralization test

Drug Discovery Services

Metabolism

  • » Liver Microsomal Stability
  • » Hepatocyte Stability
  • » CYP INDUCTION
  • » Plasma Stability
  • » CYP450 Inhibition & TDI
  • » CYP450 phenotyping

Protein Binding & Partitioning

  • » Plasma protein binding
  • » Tissue homogenate binding
  • » RBC-Plasma partitioning

In Vitro Cytotoxicity

  • » Cell-line derived Monolayer & 3D spheroids
  • » Hepatocytes
  • » hERG binding
  • » IC50/EC50 determination

In-Vivo Pharmacokinetics

  • » Serial bleed PK in mice and rat
  • » Cassette dosing PK
  • » Infusion PK
  • » Brain-Plasma & tissue distribution studies
  • » Excretion studies
  • » Formulation screening
  • » WinNonlin for PK parameters

Bioanalytical Services

  • » Bioanalytical Method Development
  • » Bioanalytical Method Validation
  • » Sample Analysis for Toxicokinetic (TK) / Pharmacokinetics (PK)
  • » Analysis of drug level in various matrices
  • » Extraction methods (precipitation, LLE & SPE)
  • » Excretion studies
  • » Formulation screening
  • » WinNonlin for PK parameters