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Manufacturing

Production readiness, documented end to end

The company profile documents COVID-19 vaccine production readiness across upstream and downstream processes, formulation, fill-finish, and supporting systems. The figures below are reproduced from that source document and presented as documented readiness — not as current commercial output.

Figures are sourced from the official company profile. They describe documented production readiness and must not be interpreted as current operating capacity, present-day certification, regulatory approval, or commercial output.

Process flow

From upstream to finished vials

  1. A

    Upstream Process

    Cell propagation and inoculation using 1 set bioreactor system with capacity of 20 L, up scaling to 200 L.

    • Cell Propagation and Inoculation
    • 1 set bioreactor system, 20 L capacity, up scaling to 200 L
  2. B

    Harvesting and Purification

    Harvesting and purification of bulk antigen prior to storage.

    • 1 harvesting tank (200 L)
    • 2 mobile tanks (200 L)
    • 1 separator machine
    • 1 ultrafiltration machine
  3. B

    Ready to Fill Bulk Antigen

    Bulk antigen stored and controlled in a sterile area prior to downstream processing.

    • 5 coldrooms (sterile area) with total area of 250 m³
    • Total effective storage area (40%) equal to 100,000 litres
    • Documented equivalent: 200,000,000 doses
  4. 2

    Downstream Process — Formulation

    Formulation stage using dedicated mobile tanks.

    • 6 mobile tanks with volume of 200 litres each
    • Total effective process capacity equal to 1,200 litres
    • Documented equivalent: 2,400,000 doses
  5. Filling

    Filling, Capping, Inspection, Labelling, Packaging, Storage

    Fill-finish operations with documented capacities.

    • Filling: 1 set filling machine, capacity 15,000 vial/hour — volume 5 ml/vial
    • Operation time 16 hours/day (bottle neck)
    • 15,000 vial/hour × 16 hours = 240,000 vials/day (equal to 1,200 litres formula)
    • Documented equivalent: 2,400,000 doses/day
    • Capping: 1 set capping machine
    • Vial inspection: 1 set
    • Labelling: 1 set
    • Packaging: 1 set
    • Storage: included
  6. Vial Washing

    Vial Washing and Dry Heat Sterilization

    Vial washing and sterilization supporting the fill-finish line.

    • 1 set vial washing and dry heat sterilization machine
    • Capacity: 20,000 vial/hour

Supporting systems

Utility and process support equipment

  • Inactivation: 9 inactivation tanks with capacity of 2,000 litres each
  • White Oil Preparation: 1 heating oil tank (3,500 L), 2 cooling oil tanks (3,500 L)
  • Water Phase Preparation: 3 premix tanks (1,000 L)
  • Emulsification: 3 emulsification tanks (1,000 L)
  • Finish tanks: 1 finish tank (3,500 L), 1 finish tank (4,500 L)
  • Vial Washing Machine: 1 set, 20,000 vials/hour, ultrasonic vial washing
  • Filling & Rubbering: 1 set filling machine, 20,000 vials/hour
  • Capping: 1 set capping machine, 20,000 vials/hour
  • Labelling: 1 set labelling machine, 20,000 vials/hour

Workshop A

720,000,000 doses/year

The company profile documents Workshop A at 720,000,000 doses/year, alongside a separate documented figure of 2,880,000,000 doses/year. These figures are reproduced as documented readiness and are not presented as current commercial output.

Discuss production with Biotis

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