Facilities and Process Capabilities

OncoGenerix can employ single use or reusable equipment and is fully scalable from 1 to up to 1,000 liters based on client need.

The baseline facilities and technology employed by OncoGenerix are highly flexible allowing a range of product types, 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.

With a capacity of 30 million vials per year OncoGenerix’s facility can process from 2 mL to 100 mL vials within the following integrated unit operations (with format parts for 2, 5, 10, 20, 50 & 100mL vials):

  • Equipment and Component preparation (separate areas for filling and formulation):
    • ISO 8 environment (Grade D) background.
    • Sterilization transfer ISO 7 environment (Grade C) background.
    • Stopper and overseal preparation and sterilization.
    • Equipment preparation and sterilization.
  • Formulation:
    • Isolator based.
    • ISO 7 environment (Grade C) background.
    • Single use or reusable formulation Ootions.
    • 0.5 to 500 liters with N2 overlay.
  • Vial Washing and Depyrogenation
    • ISO 8 environment (Grade D) background.
  • Filling, stoppering and capping:
    • Isolator based creating ISO 5 (Grade A) environment.
    • ISO 7 environment (Grade C) background.
    • 0.5mL to 100mL fill range with N2 overlay.
    • Peristaltic and positive displacement filling options.
  • Lyophilization and Automatic Loading and Unloading:
    • Isolator based creating ISO 5 (Grade A) environment.
    • ISO 7 environment (Grade C) background.
    • 2 X 15m2 lyophilizers.
    • N2 stoppering.
  • Exterior Vial Decontamination
    • Isolator based.
    • ISO 7 environment (Grade C) background.

Facility and Process Features

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

  • Environmental monitoring system for all GMP areas (recording and generating alarms for temperature, pressure and humidity) with information displays throughout the facility.
  • Building automation system (HVAC and support utility systems) with information displays throughout the facility.
  • 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 utility systems:

  • Purified water generation and distribution system:
    • 4,100Ltrs / Hr.
    • 20,000Ltrs storage system.
  • Water for injection generation and distribution:
    • 3,300 Ltrs / Hr.
    • 10,000 Ltrs storage system.
  • Pure steam generation and distribution:
    • 1,600 Kg / Hr.
  • Compressed air generation and distribution.
  • Nitrogen distribution.
  • 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 incorporates the following redundant and back up 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.
  • Back up generator system.

Bioburden and Contamination Control

The facility is purposely designed to handle products including:

  • Solution and suspension products.
  • Lyophilized products.
  • Cytotoxic and potent products.

To allow for this flexibility while maintaining enhanced sterility assurance, bioburden and endotoxin control, effective cleaning and contamination control, the facility incorporates the following key features:

  • Enhanced sterility assurance:
    • All manufacturing steps are undertaken within isolator systems.
    • 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 with single pass air systems (other than the final packaging area):
      • 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 ensure unidirectional flows.
    • 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 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 in the event the product is released from the isolator.

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OncoGenerix USA, Inc. is a United States corporation located in San Diego, California. An exclusive distributor of all the products and services.


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