Founded in 2016, Dragon Sail Pharmaceutical Co., Ltd. is a high-tech enterprise focusing on antibody drug CDMO/CMO services.
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Founded in 2016, Dragon Sail Pharmaceutical Co., Ltd. is a high-tech enterprise focusing on antibody drug CDMO/CMO services
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Dragon Sail Pharmaceutical has built the first cross-free antibody plant in Lin-gang Special Area of China (Shanghai) Pilot Free Trade Zone, China, with a total investment of nearly RMB 700 million and a production scale of up to 12,000L. It is currently one of the largest mAb production bases in Shanghai, as well as one of the most cutting-edge mAb production plants in the world.
Adhering to the concept of "Quality by Design", Dragon Sail Pharmaceutical strictly follows GMP requirements, which covers the whole business management level from operation management, manufacturing, quality inspection, warehouse management, real-time monitoring of equipment operation, etc., thus achieving real-time tracking and tracing of equipment conditions, material status, production execution and visual management of workshop control process. Currently, it has passed the EU QP audit.
The pioneering NONCROS® cross-free antibody production technology boasts the advantages of compliance, high yield, speed and cost effectiveness. It complies with the requirements for co-linear production of multiple products, and greatly improves the efficiency of plant facilities, equipment and personnel, featuring high overall operational efficiency and cost performance, thus maximizing productivity and cost effectiveness.
Dragon Sail Pharmaceutical is equipped with international advanced Sartorius and Cytiva bioreactors of different sizes (2000L\500L\200L), Sartorius freeze-thaw system, Cytiva protein chromatography purification system, as well as production line of syringe injection by Tofflon and Bosch, with preparation specifications including 5ml/10ml/20ml, etc., which can meet the needs of different product specifications, with an annual capacity of more than 460,000 pieces.
Dragon Sail Pharmaceutical has established Manufacturing Execution System (MES), Warehouse Management System (WMS), Laboratory Information Management System (LIMS), Quality Information Management System (QMS) and other systems, and created the integration between all systems to realize the integrated application of smart manufacturing business management. In addition, it is also equipped with the data acquisition and monitoring system SCADA and the environmental monitoring system BMS/EMS.
Dragon Sail Pharmaceutical has built the first cross-free antibody plant in Lin-gang Special Area of China (Shanghai) Pilot Free Trade Zone, China, with a total investment of nearly RMB 700 million and a production scale of up to 12,000L. It is currently one of the largest mAb production bases in Shanghai, as well as one of the most cutting-edge mAb production plants in the world.
Adhering to the concept of "Quality by Design", Dragon Sail Pharmaceutical strictly follows GMP requirements, which covers the whole business management level from operation management, manufacturing, quality inspection, warehouse management, real-time monitoring of equipment operation, etc., thus achieving real-time tracking and tracing of equipment conditions, material status, production execution and visual management of workshop control process. Currently, it has passed the EU QP audit.
The pioneering NONCROS® cross-free antibody production technology boasts the advantages of compliance, high yield, speed and cost effectiveness. It complies with the requirements for co-linear production of multiple products, and greatly improves the efficiency of plant facilities, equipment and personnel, featuring high overall operational efficiency and cost performance, thus maximizing productivity and cost effectiveness.
Dragon Sail Pharmaceutical is equipped with international advanced Sartorius and Cytiva bioreactors of different sizes (2000L\500L\200L), Sartorius freeze-thaw system, Cytiva protein chromatography purification system, as well as production line of syringe injection by Tofflon and Bosch, with preparation specifications including 5ml/10ml/20ml, etc., which can meet the needs of different product specifications, with an annual capacity of more than 460,000 pieces.
Dragon Sail Pharmaceutical has established Manufacturing Execution System (MES), Warehouse Management System (WMS), Laboratory Information Management System (LIMS), Quality Information Management System (QMS) and other systems, and created the integration between all systems to realize the integrated application of smart manufacturing business management. In addition, it is also equipped with the data acquisition and monitoring system SCADA and the environmental monitoring system BMS/EMS.