GMP DRUG PRODUCT MANUFACTURING
Flexible Aseptic Filling Solutions
Our integrated drug product and finished goods services offer agile and flexible solutions for clinical and commercial products. Our aseptic fill-finish lines are designed for high-throughput performance and flexible batch sizes.
Industry-Leading Vial Filling
Our drug product services include the following formats.
- Vials (Range: 2-50R; Standard: 10R, 20R)
- Pre-filled syringes (Range: 0.5-2.25ml, Standard: 1 mL with 1mL pre-filled syringes)
- Auto-injector (Range: 0.5-2.25ml, Standard: 1 mL)
Extending beyond GMP manufacturing, our services include clinical labeling, secondary packaging, cold chain transportation, storage, global logistics and distribution to provide our customers with a truly one-stop experience.
Comprehensive Capabilities
2000+
DP Batches Completed
>99.8%
Batch Success Rate
30+
Global Regulatory Approvals*
*FDA IND/EMA IMPD: 20+ ,TGA EC: 10+, FDA BLA: 1, BPOM NDA: 1
2-3
Month Tech Transfer for Finished Goods
Drug Product Formulation Development
- Stainless steel or single-use system
- Temperature controls
Aseptic Filling Services
- Grade A
- Open/active RABS
- Vials (1mL – 100mL)
- Stainless steel or single-use options
- 100% IPC weight check
Lyophilization
- Two GEA units
- Two Optima units
- Automated load/unload system
- Cycle development service
Inspection
- Manual
- Semi-automatic
- Automatic
Storage
- Controlled room: 20–24°C for Grade A/B/C
- Walk-in cold room: 2–8°C
- Freezer: -40° (±10°)C in Suzhou
- 40° (±5°)C in Hangzhou
- Deep freezer: -70° (±10°)C
Labeling & Packaging
- Printing and labeling
- Packaging
- Serialization
Quality Control
- In-process and release testing
- Stability testing
- Biosafety testing
- Media fill
Drug Product Capabilities
LINE 1
Liquid & Lyophilized Vial
- Batch Size: 1,000 L
- Lyophilization: 2R / 6R / 10R / 20R / 50R (For 20R - 17,000 vials per batch)
- Filling: 400 vials/min (0.1 mL – 50 mL vials)
LINE 2
Liquid & Lyophilized Vial
- Batch Size: 1,000 L
- Filling: 400 vials/min (0.1 mL – 50 mL vials)
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