The production workshop has obtained the Drug Production License and completed Phase 1 and Phase 2 construction, with a building area of approximately 30000 square meters and a clean area of 18000 square meters. Each workshop is equipped with an independent clean engineering system and air conditioning system to avoid cross contamination;

The production platform has currently reached a cultivation scale of 40000 liters, including 4 × 2500L and 2 × 3 × 5000L stainless steel reactors, well-equipped CIP (online cleaning)/SIP (online sterilization) facilities, which can be cleaned and sterilized multiple times, equipped with strict cleaning verification methods, can eliminate dependence on disposable reactor consumables, reduce costs, bring higher profits to customers, and ensure the consistency and robustness of cell culture processes;

Diversified production can be carried out, and production processes such as perfusion culture and flow addition culture can be easily achieved. Alternating tangential flow (ATF) technology can be used for 500L scale perfusion production;

Both Phase 1 and Phase 2 production lines are equipped with independent upstream and downstream production areas, as well as their own independent CIP/SIP systems. The layout of pedestrian and logistics channels in each functional area is reasonable to ensure compliance with regulatory requirements for biological product production facilities.

The pharmaceutical water system, air conditioning purification system, compressed air system, and various production equipment in the workshop have undergone comprehensive 3Q validation. According to the life cycle principle, regular re validation is carried out to fully comply with production processes and regulatory requirements, and to continuously ensure stable performance.