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Antibody Drug Product(DP) Manufacturing

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Thousand Oaks Biopharmaceuticals’ Nantong formulation suite uses a single-use solution preparation system. The filling line features a Bosch fully automated integrated system (filling, stoppering, capping) with a Restricted Access Barrier System and Tofflon freeze-dryers, capable of producing vial injectables, vial lyophilized powders, and pre-filled syringes (PFS).

Core Capabilities

  • Bosch isolator vial filling line with 100% in-process IPC weighing for filling accuracy.
  • VHP pass-through windows, moist heat sterilizers, and clean devices ensure sterility.
  • Equipped with a bottle washer (inner/outer wall cleaning) and tunnel oven (decontamination/depyrogenation).
  • Single -use consumables in compounding/filling prevent contamination/cross-contamination.
  • Line compatible with 2R-20R (6-needle) injectables/lyophilizates, expandable to 30R/50R, max 200 vials/min.
  • 10m² and 25m² lyophilizers equipped with independent auto-loading/unloading system.
Vial filling line and lyophilized formulation capacity details are 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)
2R 12000 96000 40320
6R 12000 96000 20295
10R 12000 96000 20295
20R 6000 48000 11223
By using the TRUKING prefilled syringe filling line, the production of 1mL standard, 1mL slender, 3mL standard, and 3mL cartridge vials can be achieved.
PFS filling line capacity details are shown in the table below.
Prefilled syringe specifications Filling speed (syringes/hour) Output (syringes in 8 hours)
Mechanical stoppering Vacuum stoppering Mechanical stoppering Vacuum stoppering
1mL standard 10000 7000 80000 56000
1mL slender 10000 7000 80000 56000
3mL standard 8000 6000 64000 48000
3mL cartridge 6000 48000