Production Capabilities

The baseline facilities and technology employed by OncoGenerix are highly flexible. This allows us to handle 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 by OncoGenerix encompass the following process capabilities:

• Formulation:
  • 1Ltr. to 1,000Ltrs
  • Low bioburden
  • Suspensions & 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 & Packaging:
  • 2mL to 100mL vial range
  • Automatic vial cosmetic and particulate inspection
  • Vial leak integrity testing
  • Labeling
  • Packaging

Facility Bioburden & Contamination Control Features

OncoGenerix’s facility incorporates the following bioburden and contamination control features to allow for multi-product aseptic processing: 

• Enhanced sterility assurance:
  • All manufacturing steps are undertaken within ISO 5 isolator systems located in ISO 7 areas.
  • All transfers into the isolator system are undertaken using closed transfer systems.
  • Integrated environmental monitoring systems (viable and non-viable) in the isolator system.
  • Automation to minimize personnel interaction with the process.
• Bioburden and endotoxin control:
  • Single-use pre-sterilized equipment.
  • Pre-sterilized equipment and utensils.
  • Stringent personnel gowning requirements.
  • High level of clean room finishes to ensure effective cleaning and sanitization.
• Contamination Control:
  • The facility is provided with the following fully segregated unit operations:
  • Formulation equipment GMP cleaning and preparation.
  • Formulation.
  • Formulation equipment decontamination.
  • Filling equipment GMP cleaning and preparation.
  • Filling of solution and lyophilized products.
  • Filling equipment decontamination.
  • Vial inspection and packaging.
  • Vial inspection and packaging equipment decontamination.
• All unit operations are laid out to ensure unidirectional flows.
• Single pass air to ISO 7 areas
• Gowning in GMP areas with secondary gowning in GMP areas with product exposure.
• Cleaning
  • High quality seamless surface finishes in all GMP areas to allow for effective cleaning.
  • Single-use systems for all product contact parts:
    • API and buffer formulation vessels.
    • Product fluid path and filter assembly.
    • Filling needles, filling tubing and filling surge vessels.
• Process containment:
  • The facility and technology work together to enable the following containment strategy:
    • Primary level containment is provided by maintaining the product within the product pathway (i.e., the formulation vessel and fluid path) with the filling needles designed to minimize aerosoling of the product.
    • Secondary level containment is provided by the isolator system in the event of a vial breakage or product spill within the isolator system.
    • Tertiary level containment is provided by the room space.

Facility Design Features

To provide a robust and controlled operational environment, the facility is provided with the following key features:

• Seamless modular clean room system in all GMP areas.
• Walk-on ceilings for external service and maintenance.
• Door interlock system and card access control system.
• Video monitoring of all areas.
• Synchronized clock system.
• The facility contains the following GMP utility systems:
  • Purified water generation and distribution system.
  • Water for injection generation and distribution.
  • Pure steam generation and distribution.
  • Compressed air generation and distribution.
  • Nitrogen distribution.
• The facility contains the following commissioned utility systems:
  • Plant steam generation and distribution.
  • Heating hot water generation and distribution.
  • Chilled water generation and distribution.
  • Waste treatment and neutralization system.
• The facility and process incorporate the following redundant and backup systems:
  • High volume WFI storage (sufficient to complete any production batch).
  • Redundant WFI distribution system.
  • High volume purified water storage (sufficient to complete any production batch).
  • Redundant purified water distribution system.
  • Redundant air compressors.
  • Redundant steam boilers with dual fuel services (oil and gas).
  • Redundant heating hot water distribution system.
  • Redundant chilled water and distribution system.
  • Redundant power transformers.
  • UPS to all critical control systems.
  • Backup generator system.