Thursday, December 09, 2021
GenScript ProBio announced today the opening of China's largest commercial GMP plasmid manufacturing facility during a ceremony at the site in Zhenjiang, Jiangsu Province. The 6,400-square-meter manufacturing plant enables GenScript ProBio to offer global customers a one-stop service for plasmids - from preclinical study (IIT), to investigational new drug (IND) filing, to clinical trial and commercial manufacturing - to accelerate the innovation and development of high-quality cell and gene therapy mRNA drugs.
As GenScript ProBio's second GMP plasmid manufacturing facility, the plant more than doubles the company's production capacity and strengthens its position as a leading CDMO. It enables the company to offer services including off-the-shelf LentiHelpTM plasmids, Pro grade plasmids for preclinical development, plasmids CMC study for IND filing, clinical GMP plasmids for early clinical trials, and cGMP plasmids for late-phase and commercialization.
The facility also expands GenScript ProBio's operations, which already included the largest commercial GMP plasmid manufacturing facility in China. GenScript ProBio is the first CDMO enterprise in China to have separate production facilities for plasmids and viral vectors. GenScript ProBio is the only GMP manufacturing platform in China that provides in vitro transcription (IVT) template linearized plasmids for mRNA vaccines.
In 2020, GenScript ProBio helped Suzhou Abogen secure the first clinical approval for an mRNA vaccine in China, and in October 2021, it reached an agreement with Abogen and Walvax for commercial manufacturing of the vaccine. Besides helping many mRNA vaccine enterprises in China obtain clinical approvals by NMPA, GenScript ProBio also supported companies in South Korea and the United States as they sought clinical approvals for mRNA vaccines in South Korea and Japan.
“GenScript ProBio adheres to the mission of‘Innovation through Collaboration.’Our extensive experience and high-quality plasmid viral vector manufacturing services have helped customers worldwide advance their clinical trials and commercial development programs," said Dr. Brian Min, CEO of GenScript ProBio, during a speech at the opening ceremony. "Our GMP plasmid manufacturing for mRNA vaccine development has also helped our customers in the fight against the COVID-19 pandemic."
Since its founding GenScript ProBio has supported the development of cell and gene therapies. In 2018, GenScript ProBio helped its subsidiary Legend Biotech secure the first CAR-T clinical approval in China. In 2019 and 2020, GenScript ProBio, as a service provider of Xiangxue, helped it secure the first TCR-T project approval from the NMPA, as well as approval from the FDA. The filing in China took only 54 working days from the submission of the IND application to the receipt of the Notification of Drug Clinical Trials, setting a record for the fastest new drug approval in 2019 in China.