Drug Product
Production
Intellective Bio offers aseptic filling services that ensure the highest quality and safety for large-scale production. Our flexible drug product lines support multiple dosage forms, including vials (liquid), lyophilized formulations, and pre-filled syringes (PFS), with a daily capacity of up to 330,000 units. The facilities have successfully passed NMPA inspections and EU QP on-site audits, providing strong assurance for global regulatory filings and commercial manufacturing.
DP1
The DP1 production line is a flexible small-scale line for vial-based liquid injections and lyophilized formulations, dedicated to meeting the production needs of clinical-stage samples and small-batch commercial supplies.
Filling Speed: 20 vials/min
Lyophilization Area: 2 m²
Maximum Batch Capacity: 5,000 vials (units)/batch
DP2
The DP2 production line is a high-speed, intelligent production line for prefilled syringes/cartridges injections, covering the entire process flow of prefilled syringe/cartriges filling, visual inspection, and auto-injection pen assembly.
Prefilled Syringe Filling Line: 200 units/minute
Fully Automatic Assembly System: 60 units/minute
Automatic Visual Inspection Machine: 140 units/minute
Maximum Batch Capacity: 100,000 units/batch
DP3
The DP3 production line is a high-speed vial formulation line designed for large-scale commercial manufacturing, boasting robust integrated production capacity.
Filling speed: 400 vials/minute
Maximum Batch Capacity: 400 vials (cartons)/minute
Packaging Line Speed: 400 vials (cartons)/minute
Lyophilization Area: 25 m²
DP4
The DP4 production line is a high-speed vial formulation line designed for large-scale commercial manufacturing, equipped with an automatic visual inspection machine and a fully automatic secondary packaging line.
Packaging combinations: 2R to 50R
Filling Speed: 400 vials/min
Lyophilization Area: 50 m²
DP5
The DP5 pilot production line equipped with a multi-functional integrated intelligent filling line, it supports small-scale filling of multiple dosage forms including liquid injections, lyophilized formulations and prefilled syringes. This flexible production line enables us to respond rapidly to market demands, carry out small-batch and diversified production, and meet the personalized needs of clients.
DP6(ADC)
The DP6 production line is specially designed for the filling of highly potent ADC products. Located on the 2nd floor of the production annex building, it meets the GMP commercial manufacturing requirements for products under OEB5.
Filling Speed: 100 vials/min
Lyophilization Area: 10 m²
DP7
The DP7 production line incorporates an imported fully automatic prefilled syringe filling line from Germany’s Bausch+Strobel, along with a complete secondary packaging line including an automatic visual inspection machine and a fully automatic high-speed auto-injection pen assembly line.
Filling Speed: 400 units/min
Maximum Batch Capacity: 300,000 vials/batch
Current Capacity for Storage at -40°C
-40°C Cold storage
2-8°C Cold storage
8 Racks with a capacity of 7.3 million units
20 Racks with a capacity of 3.65 million units
Warehouse Capacity Supports
Large-Scale Manufacturing
| Storage area | Area (㎡) | Pallet slots | Storage capacity (for Lerodalcibep) |
| Room temperature (10-30 ºC) | 2,424 | 1,728 | N/A |
| Room temperature (15-25 ºC) | 2,050 | 1,257 | N/A |
| Raw material (2-8 ºC) | 492 | 324 | N/A |
| DP (2-8 ºC) | 556 | 336 | 7,300,000 vials |
| DS (-40 ºC) | 272 | 1,834 | 15,000,000 vials |
