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Product Capabilities

The baseline facilities and technology employed are highly flexible, allowing handling of a wide range of products, including:

  • Low bio-burden and aseptically-formulated products.
  • Suspension and solution products.
  • Lyophilized products.
  • High-potency products.
  • Cold chain products.
  • Light sensitive products.
  • Solvent based products.
  • N2 formulation and filling.

Process Capabilities

The baseline facilities and technology employed encompass the following process capabilities:

  • Formulation:
    • 1Ltr. to 1,000Ltrs.
    • Low bioburden.
    • Suspensions and solutions.
  • Component Preparation:
    • Stopper washing, siliconization and sterilization.
    • Overseal sterilization.
  • Filling / Stoppering / Capping:
    • 2mL to 100mL vial range.
    • 0.5mL to 100mL vial filling range.
    • Automated weight checking.
    • Peristaltic / positive displacement filling options.
    • Solution batches up to 100,000 10mL vials.
  • Lyophilization:
    • 2mL to 100mL vial range.
    • Automatic loading / unloading.
    • Integrated CIP / SIP.
    • Lyo batch sizes up to 50,000 10mL vials.
  • Automated Inspection and Packaging:
    • 2mL to 100mL vial range.
    • Automatic vial cosmetic and particulate inspection.
    • Vial leak integrity testing.
    • Labeling.
    • Packaging.
OncoGenerix