GenScript ProBio Opens China’s Largest Commercial GMP Plasmid Manufacturing Facility

Rhea-AI Summary

GenScript ProBio has inaugurated China's largest GMP plasmid manufacturing facility in Zhenjiang, Jiangsu Province, enhancing its service offerings for plasmids used in cell and gene therapy. The 6,400-square-meter plant significantly increases production capacity and positions the company as a leading Contract Development and Manufacturing Organization (CDMO). It provides comprehensive plasmid services from preclinical studies to commercial manufacturing, supporting mRNA vaccine development and clinical trial approvals globally, including in China and South Korea.

Positive

• New GMP facility doubles production capacity for plasmids.
• Enables comprehensive services from preclinical to commercial manufacturing.
• Strengthens position as a leading CDMO in China.
• Supports global mRNA vaccine development and clinical trial approvals.

Negative

• None.

 Continued manufacturing expansion facilitates one-stop plasmid services for global customers in Europe and beyond

NANJING, China--(BUSINESS WIRE)-- 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.

GenScript ProBio’s largest commercial GMP plasmid manufacturing facility in China opens in Zhenjiang, Jiangsu Province. (Photo: Business Wire)

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 LentiHelp^TM 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.

About GenScript ProBio

GenScript ProBio is the biologics CDMO segment of GenScript Biotech, proactively providing end-to-end service from drug discovery to commercialization with proactive strategies, professional solutions and efficient processes in antibody drug and gene and cell therapy to accelerate drug development for customers. https://www.genscriptprobio.com/

View source version on businesswire.com: https://www.businesswire.com/news/home/20211208005385/en/

Berkan Unal, Director Business Development

E-mail: berkan.unal@genscript.com

Phone: +49 176 233 22 401

Shanlin Yang, Media Relations Manager

E-mail: shanlin.yang@genscript.com

Phone: +86 150 7138 1167

Source: GenScript ProBio

FAQ

What is the significance of GenScript ProBio's new GMP facility opened in Zhenjiang?

The new GMP facility enhances GenScript ProBio's capability to manufacture plasmids, doubling its production capacity and allowing it to provide comprehensive services for cell and gene therapy.

How does the new facility impact mRNA vaccine development?

The facility supports the production of GMP plasmids necessary for the development of mRNA vaccines and accelerates clinical trials for vaccine manufacturers.

What is the location of GenScript ProBio's new facility?

GenScript ProBio's new facility is located in Zhenjiang, Jiangsu Province, China.

What role did GenScript ProBio play in the approval of mRNA vaccines in China?

GenScript ProBio has assisted companies, including Suzhou Abogen, in securing clinical approvals for mRNA vaccines, contributing to their rapid development.

When did GenScript ProBio help Legend Biotech secure CAR-T approval?

GenScript ProBio supported Legend Biotech in achieving the first CAR-T clinical approval in China in 2018.