Services
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– Aseptic filling
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– Lyophilization
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– Drug product packaging
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– In-process control tests
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– Drug product release test
Advantages
ADC lyophilized production lines
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Established pilot-scale and commercial-scale manufacturing workshops and equipped with grade OEB5 isolators
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Single use filling system, isolator based filling line, and automatic loading and unloading and lyophilized system
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Commercial workshop with the 2R- 50R drug product capability, up to 200 vials/min running speed
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Equipped with rapid transfer port (RTP), online weighing and light protection, 100% full weighing control in use for pilot-scale production line, and statistical sampling weighing module with dual-weighing complementary function in use for commercial production
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Designed with independent isolator chamber, including filling, automatic loading and unloading, and capping. The design allows to switch between freeze-drying and liquid-injectable, to achieve continuous production and maximize the productivity
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Equipped with 5 ㎡ and 20 ㎡ lyophilizers, both of which have fully automatic loading and unloading systems
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Over than 20 production batches have been successfully completed
Capacity of Lyophilized ADC
|
Vial (mL)
|
2
|
6/8
|
10/15
|
20
|
50
|
|
5 ㎡ lyophilizer
(Vials/batch)
|
22,000
|
11,000
|
9,000
|
6,000
|
3,000
|
|
20 ㎡ lyophilizer
(Vials/batch)
|
80,000
|
42,000
|
35,000
|
23,000
|
13,000
|
|
Equipment