一、 Original solution DS

The production workshop has obtained a Drug Production License and has 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 independent clean engineering systems and air conditioning systems 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, equipped with complete 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 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 undergo comprehensive 3Q verification. According to the principle of life cycle, regular re verification is carried out to fully comply with production process and regulatory requirements, and can continuously ensure stable performance.

二、 Preparation DP

◆ We have a fully automated production line from Bosch in Germany, which can produce liquid formulations in 2ml, 6ml, 15ml, 25ml, and 50ml penicillin bottles, as well as freeze-dried formulations in 6ml, 15ml, and 50ml penicillin bottles;

The packaging speed can reach 24000 bottles/h, and multiple modes of IPC monitoring can be set to ensure that the product loading meets the process requirements;

◆ Equipped with a 15 ㎡ large freeze-drying machine, adopting fully automatic feeding and discharging and CIP/SIP system to avoid human factors, ensuring product sterility and stable product quality;

◆ Install an online monitoring system on the filling line to ensure that the entire packaging process is controlled and that the production environment meets the requirements for cleanliness;

◆ Pre filled syringes can be used for filling, and products can be directly filled into 1.0ml (slender) and 2.25ml syringes. Patients can use medication directly to avoid introducing risks during the later drug extraction and transfer process;

三、 Split packaging

1. Packaging

Packaging line: fully automatic BOSCH washing and drying linkage packaging line complies with GMP and EU standards. Packaging specifications: can be divided into multiple specifications (2R-50R) penicillin bottles for the production of liquid and lyophilized formulations

Packaging speed: According to packaging specifications, the packaging speed is 24000 bottles/hour

Aseptic operation: 200+batches of packaging production, zero contamination

Validation of simulated canned culture medium, once/six months

Personnel changing confirmation, once per year

2. Packaging