Global Compliant Biopharmaceutical CDMO Service Platform – International Production Capacity + Full Dosage Form Coverage
As a key project under Changchun City's "Changchun Pharma Valley" strategic plan, the production base has a total investment of over 700 million RMB, with a total construction area of 34,000 square meters, including more than 24,000 square meters of production facilities compliant with international GMP standards.
1. Prokaryotic Drug Substance Platform
- Scale: Full-process production from 20L → 300L → 3300L, with an annual capacity of 480,000 liters
- Supporting Services: Integrated formulation and filling services
2. Eukaryotic Drug Substance Platform
- Flexible Cultivation: Multi-scale production lines with disposable bioreactors (50L/500L/2000L)
3. International Formulation Production Lines
- Topical Preparations: Dedicated production line for sterile gels in aluminum-plastic/aluminum tubes
- Injectables:
- Dual-vial (lyophilized/liquid) production line, supporting multi-format switching (including pre-filled syringes), with an annual capacity of 200 million units
- Dedicated pre-filled syringe line, annual capacity of 8 million units
- Cartridge line, annual capacity of 8 million units
- Full-System Certifications: GMP approvals from China NMPA, US FDA, EU EMA, and WHO-PQ
- Global Supply Capability: Compliant with international GMP standards, supporting multinational regulatory submissions and commercial production