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 bioreactor (SUB) trains with separate purification lines. These production suites are suitable for clients who are ready for preclinical to phase-I/II drug substance manufacturing. The GMP production line has, two seed trains with single 500L production bioreactor. The non-GMP production line is a single seed train with two 200L production bioreactors. The total manufacturing area at pilot production facility spans for about 10,000 ㎡. (108,000 sqft)

3. The cells are expanded through a seed train and transferred to a production bioreactor. At the end of culture, clarified harvest is further purified downstream using multiple chromatography columns, viral filtration, tangential filtration, and final filtration steps to produce drug substance.

4. 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 a month

    • Cost efficiency

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

    • Compliant with cGMP requirements

  • Responding to customer needs
    • Supports 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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