1. The quality system at the pilot production complies with cGMP. There are two production lines with 4×200L single use bioreactors (SUB) and 1×500L SUB. The total area of the facility is 10,000㎡ (108,000 sqft).
2. The pilot production site is equipped with two single use production lines, which can meet the demand for preclinical to Phase-I/II bulk production. The GMP production line is equipped with two 200L production bioreactors and one 500L production bioreactor. The non-GMP production line is equipped with two 200L production bioreactors. The total manufacturing area of pilot production facility spans for about 10,000 ㎡ (108,000 sqft).
3. The two single use production lines enable faster change-over time and avoid cross contamination and shorten production cycle time.
Delivery within one month
Cost efficiency
Suitable for preclinical and clinical phase I/II materials
Compliant with cGMP requirements
Meet global clinical drug development & manufacturing needs
Flexibility with process configurations
• DS Plant
• QC Lab
• Warehouse
• Utility