The pilot manufacturing base complies with GMP standards and includes 1 GMP production line and 1 non-GMP production line, equipped in total with 4×200 L and 3×500 L single-use bioreactors. With a total production area of approximately 10,000 m² (108,000 ft²), it meets drug substance manufacturing needs from preclinical through Phase I/II.
The pilot manufacturing base complies with GMP standards, with 1 GMP production line and 1 non-GMP production line, equipped in total with 4×200 L and 3×500 L single-use bioreactors.
The 2 single-use production lines can meet drug substance manufacturing requirements from preclinical through Phase I/II: the two lines are equipped with four 200 L and three 500 L single-use bioreactors in total.
Both production lines use single-use process systems, enabling rapid linkage of upstream and downstream processes and fast product changeover while ensuring product quality and at the same time shortening production cycles.
The facility comprises four independent functional zones operating separately without interference, safeguarding product quality and supply chain security.
Single-use bioreactor production area, covering the full drug substance workflow from cell culture to harvest
Equipped with chromatography, mass spectrometry and other analytical platforms supporting in-process control and release testing
Zoned storage with expiry and batch management, ensuring traceability of the materials supply chain
Independent operation and management of utility systems, providing stable and reliable support for manufacturing
A 200–500 L single-use GMP line delivering within one month, supporting global clinical drug supply needs.
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