◆ We are experienced in the production of various expression systems, such as CHO, HEK293, etc., and can provide a complete solution protocol of Phase IND for partners; ◆ With the cell amplification room built with a high standard, we can perform bank establishment for cGMP cells. At present, we have completed the bank establishment with over 30 stains; ◆ The production workshop is established on the basis of GMP requirements, which complies with the clinical submission requirement of China, USA, and European countries, etc.; ◆ Based on the product characteristics, we can perform the R&D production of infusion culture, fed-batch culture, and other production process;◆ We can provide disposable and stainless steel production systems. The disposable production system includes 50L and 200L, and the stainless steel production system includes 50L, 200L, and 2500L. They can be flexibly chosen by clients according to the protein characteristics; ◆ The production equipment of upstream and downstream are world-known brands, such as Sartorius, GE ,and GEA. With stable and reliable performance, we can continuously provide high-quality production service on all stages for clients.

◆ 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.

◆ We own the automatic preparation production line of Germany Bosch, which can perform the liquid preparation production of 2ml、6ml、15ml、25ml, and 50ml vials, as well as the lyophilized preparation production of 6ml, 15ml, and 50ml; ◆ The filling speed can reach 24000 vials/h, and IPC monitoring of multiple modes can be set, thus ensuring that the filled volume of the product meets the process requirements; ◆ The large freeze dryer of 15 m2 was installed, with automatic feed-in/ feed-out and CIP/SIP systems to avoid the effect of human factors and ensure the sterility and stable quality of products;◆ The filling line has installed an online monitoring system to ensure the whole filling is under control and the clean environment of production meets the requirement; ◆ The filling of the pre-filled syringe can be performed and the product can be directly filled into the syringe of 1.0ml (slender) and 2.23ml syringes. The patient can use the medicine directly to avoid introducing risk during medicine extraction and transferring at a later stage.