JOINN Biologics Technology Co was set up in Zhongguancun Yizhuang Park in 2018. [joinnbio.com.cn]

JOINN Biologics Technology Co in the Zhongguancun Demonstration Zone recently passed review by the US Food and Drug Administration and was licensed for production, another milestone for the company after passing the EU Qualified Person (QP) audit.

Obtaining the license from the US FDA means that the quality system of the US production line of JOINN Biologics complies with US GMP standards. 

Meanwhile, the company's hardware facilities and software systems have also met the quality requirements for the commercial production of pharmaceuticals set by regulations in the United States. 

Established in 2018, the biopharmaceutical CDMO company is headquartered in Zhongguancun Yizhuang Park. 

Relying on research, development and production bases in China and the United States, it provides global innovative drug R&D institutions with one-stop solutions from cell line construction, feasibility research, scale-ups of process optimization and quality research to pilot trials and commercial production.

JOINN Biologics now has a core technical team with rich industry experience and knowledge of Chinese and foreign new drug regulations. It also possesses engineered cell lines with complete intellectual property rights. 

The company has set up a number of 1000L, 500L, and 200L production workshops meeting FDA and GMP standards in the United States, as well as a number of 500L and 200L production lines in Beijing. 

The company's 100,000-liter biomedicine pilot R&D and production base project in ZGC Yizhuang Park is currently under construction. It is expected that nine 2000L production lines will be completed and put into operation in 2021.