Manufacturing
200-500L Production Facilities for Early Clinical Phase

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 the pilot production facility spans approximately 10,000 ㎡ (108,000 sqft).

3. The two single-use production lines enable faster changeover, prevent cross-contamination, and shorten production cycle time.

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

    • Cost efficient

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

    • Compliant with cGMP requirements

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

    • Flexible with process configurations

Key Functional Areas of the Production Plant

• DS Plant

• QC Lab

• Warehouse

• Utility

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