200-500L Production Facilities for Early Clinical Phase

1. The quality system at the pilot production complies with cGMP. There are 2 production lines with 4×200L single use bioreactor (SUB), 1×500L SUB, total area is 10,000㎡ (108,000 sqft)

2. The pilot production site is equipped with 2 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.

Competitive Advantage
  • Project time and cost
    • Delivery within one month

    • Cost efficiency

  • Production scale and standard
    • Suitable for preclinical and clinical phase I/II materials

    • Compliant with cGMP requirements

  • Responding to customer needs
    • Meet global clinical drug development & manufacturing needs

    • Flexibility with process configurations

The production plant contains the following separate functional areas

• DS Plant

• QC Lab

• Warehouse

• Utility

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