◆ Our production workshop has obtained Drug Manufacturing Certificate and we have completed the construction of Phase I and Phase II with a building area of about 30000 m3 and a clean area of 18000 m3. Each workshop is equipped with an independent clean engineering system and HVAC system to avoid cross-contamination; 

◆ Currently, the production platform has reached the scale of 40,000L, including 4×2500L and 2×3×5000L stainless steel reactor, configuring sophisticated CIP (clean in place)/SIP (sanitizing in place) facilities for multiple cleaning and sanitization use. With strict cleaning validation approaches, the platform can get rid of the dependence on disposable reactor consumables, thus reducing costs. That can bring a higher benefit for clients and ensure the consistency and robustness of the cell culture process; 

◆ It can perform diverse production, thus the production process of infusion culture, and fed-batch culture can be achieved easily. The alternative tangential flow technology can be used for 500L’s fed-batch production; 

◆ Production lines in Phase I/Phase II are all equipped with independent upstream and downstream production areas and respective CIP/SIP systems. The layout of personnel flow and material flow corridors is reasonable, thus ensuring that the requirement of following regulations on production facilities of biological products can be met; 

◆ All-around 3Q validation is carried out for water for the pharmaceutical preparation system, HVAC system, compressed air system, and all kinds of production facilities in the workshop. Based on the life cycle principle, the re-validation will be carried out periodically. That completely complies withe the requirements of production process and regulation and can continuously ensure the performance stability.