15 April 2019 | News
The 133,000-square-meter Manufacturing Center with a GFA of 150,000 square meters will be designed and constructed in compliance with the current good manufacturing practice (cGMP) requirements of the FDA, the EMEA and the NMPA
GenScript Biotech Corp, a leading Chinese bio-pharmaceutical contract development and manufacturing organization (CDMO), held the groundbreaking ceremony for the start of construction of the GenScript-Legend Biotech Commercial Manufacturing Center.
The groundbreaking ceremony for the project was held in Zhenjiang on April 10, 2019, with officials of the Zhenjiang municipal government, leading experts in cell therapy, as well as partners and executives of GenScript, including GenScript subsidiary Legend Biotech's vice president of production Dr. David He and GenScript Biological Drug Business Unit CEO Dr. Brian Hosung Min, taking part in the exciting event.
The 133,000-square-meter Manufacturing Center with a GFA of 150,000 square meters will be designed and constructed in compliance with the current good manufacturing practice (cGMP) requirements of the FDA, the EMEA and the NMPA (National Medical Products Administration), and will specialize in plasmids and viruses manufacturing.
The plasmid service line will be equipped with single-use bioreactors for plasmid production, while regarding the virus line, suspension-based production processes and adherent production processes are planned. These production lines that feature a combined output capacity can simultaneously meet the demands of several commercial projects.
Once completed, the antibody drug manufacturing facility will meet the needs for Phase III clinical sample and commercial production. The cell production facility, a unit in full compliance with cGMP requirements of the FDA, the EMEA and the NMPA, will output commercial products for application in cell and gene therapies.
GenScript's Manufacturing Center in Zhenjiang is expected to become China's first and largest commercial center specializing in the research and development of cell and gene therapies as well as antibody biological medicines, speeding up the transformation of biologics from concept to commercial production.