Genesis Biotechnology Group
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Ocular Center of Excellence

Ocular PK & Biodistribution

  • Bioavailability, biodistribution, PK/PD
  • Exploratory (non-GLP) or regulated (GLP)
  • Single-dose or multiple-dose studies
  • Animal biosafety levels 1 & 2
  • Species: Rodent, Rabbits, Dogs, Pigs
  • Test Articles: small & large molecules, chemicals, biologics (nucleic acids, peptides, proteins, antibodies, viral vectors etc.), devices
  • Routes of Administration: topical, topical eyelid, intravitreal, intracameral, subretinal, surgical, oral gavage, intraperitoneal, intravenous
  • Tissues
    • Anterior Segment: aqueous humor, conjunctiva, cornea, lens, iris-ciliary body, trabecular meshwork
    • Posterior Segment: retina, choroid, vitreous humor, sclera
    • Other: tears, accessory glands (lacrimal, harderian, meibomian), optic nerve
    • Non-ocular: blood, urine, CSF, feces, organs
  • Bioanalysis
    • Small & large molecule
    • LC-MS/MS
    • Immunoassay
    • Analyses can be conducted following FDA GLP guidelines
    • PK statistical analysis (WinNolin)

Toxicity

  • Exploratory (non-GLP) or regulated (GLP)
  • Species: Rodent, Rabbit, Dog, Pig
  • Sub-acute, acute, chronic, dose response, tolerability, maximum tolerate dose
  • Test articles: chemicals, biologics (nucleic acids, peptides, proteins, antibodies, viral vectors etc.), devices, drug delivery systems
  • Routes of Administration: topical, topical eyelid, intravitreal, intracameral, subretinal, surgical, oral gavage, intraperitoneal, intravenous
  • Readouts
    • Ophthalmic Examination
    • Intraocular Pressure
    • Electroretinography
    • Optical Coherence Tomography
    • Histopathology
    • Molecular Biomarkers (qPCR, Immunoassays, Western Blotting)
  • In Vitro Toxicity Assays
    • Viability
    • Cytotoxicity
    • Cell Signaling/Mechanism of Action
    • Apoptosis
    • Gene Expression

Efficacy Models

  • Optic Nerve Crush
    • Species: Mice
    • Acute or chronic studies
    • Single-dose or multiple-dose studies
    • Test articles: chemicals or biologics (nucleic acids, peptides, proteins, antibodies)
    • Routes of Administration: topical, topical eyelid, intravitreal, intracameral, oral gavage, intraperitoneal, intravenous
    • Readouts
      • Ophthalmic Examination
      • Optical Coherence Tomography
      • Electroretinography
      • Histopathology
      • Immunohistochemistry
      • Molecular Biomarkers (qPCR, Immunoassays, Western Blotting)
  • In Vitro Assays
    • Cell Signaling/Pathway Activation
    • Gene Expression

Capabilities

  • Bioanalytical Detection
    • Small and large molecules
    • LC-MS/MS
    • Immunoassays
    • PK statistical analysis (WinNolin)
    • Analyses can be conducted following FDA GLP guidelines
  • Molecular Biomarkers/Biochemistry
    • qPCR
    • Immunoassays
    • Western Blots
  • Histology Services
    • Paraffin, cryotomy, plastic
    • Immunohistochemistry
    • Special Stains
  • In Vitro Assays
    • Cell Signaling
    • Gene Expression
    • Viability
    • Cytotoxicity
    • Apoptosis
  • In Vivo Imaging & Functional Assessments
    • Optical Coherence Tomography
    • Intraocular Pressure
    • Electroretinography
    • Fluorescein Angiography
    • Ophthalmic Examination