ADC Drug Product Manufacturing

  • Using Tofflon isolator liquid vial filling line, equipped with OEB5 level isolator, equipped with 10m² and 25m² lyophilizers, both with independent fully automatic loading and unloading systems;
  • The filling line is compatible with the production of 2R-50R specification injection and lyophilized formulations, with a maximum operating speed of 300 vials per minute;
  • Featuring nitrogen purging pre- and post-filling as well as nitrogen-purged stoppering during lyophilization, the lines support the production of oxygen-sensitive products.
  • Isolator orange light control and workshop yellow light control can be used for light-sensitive drugs production;
  • Rapid Transfer Ports (RTP) are implemented in the production line, equipped with VHP atmospheric clean sterilization, 100% online IPC weighing, refilling when the filling volume is insufficient, tunnel oven cooling section sterilization, and vial outer wall cleaning functions;
  • Equipped with the function of emptying the tail liquid of the filling machine, ensuring the filling yield;
  • Use disposable filling system to effectively prevent cross contamination.
The production capacity information of injection and lyophilized formulations on the filling line is shown in the table below:
Specification of vial Filling speed (vial/hour) Injection output (in 8 hours, vial/batch) Lyophilized formulations production capacity(10m³, vial/batch) Lyophilized formulations production capacity(25m³, vial/batch)
2R 18,000 144,000 43,800 100,000
6R 13,800 110,400 23,090 53,045
10R 13,800 110,400 19,300 43,000
20R 9,000 72,000 12,300 27,700
50R 3,600 28,800 6,000 15,400