ZHENJIANG, China, April 15, 2019 /PRNewswire/ -- 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.
Dr. He gave a speech during the ceremony, during which he emphasized: "Cell therapy products are 'live' medicines, and the manufacturing of high-quality and cGMP-compliant plasmid and viral vectors is one of the most critical components in the commercialization of cell and gene therapies. Legend Biotech has established a global presence in terms of commercial production. Our commercial manufacturing facility in the US will soon become operational. In our home market of China, we will work closely with GenScript's CDMO facility to facilitate commercialization of plasmid and viral vectors as well as cell production."
Ye Shengqin, Chairman of Shanghai Longyao Biotechnology Inc.,Ltd, said: "Partnerships are an important contributor to the development of innovative-oriented firms. As a strategic partner of GenScript, Shanghai Longyao Biotechnology Inc.,Ltd has awarded its CDMO business consisting of plasmid and viral preparations of two new CAR-T products featuring distinctive technology benefits to GenScript. Our collaboration is under way as planned. I believe this is only the beginning of our increasingly enhanced partnership."
Dr. Brian added: "Since its foray into the CDMO market, GenScript has grown rapidly. After successfully applying for Legend Biotech's CAR-T project, we have been awarded several IND application projects as well as ones involving plasmid and virus production, including CAR-T, UCAR-T, TCR-T and AAV gene therapy projects. In order to provide a turnkey service for the commercialization of gene and cell therapy products, GenScript planned the Manufacturing Center. As for antibody drugs, Zhenjiang's GMP facilities will meet the needs for Phase III clinical sample and commercial production. We believe that our efforts will enhance China's advantages in the development of biologics and accelerate the development of the country's pharmaceutical industry."
About GenScript
GenScript Biotech Corp is a leading Chinese bio-pharmaceutical contract development and manufacturing organization (CDMO), with extensive services in gene synthesis, peptide synthesis, antibody development, protein expression and custom biological reagents as well as providing a one-stop biological drug research and development platform. GenScript's one-stop antibody drug development solutions include antibody drug discovery (hybridoma, phage display, full human and bispecific antibodies technologies), antibody engineering (antibody humanization, evaluation and optimization of drug compounds and affinity maturation) and other services. GenScript's total cell therapy solution covers IND preparation as well as clinical sample and commercial production. Process development controls ensure compliance, data integrity ensures traceability, and all test deviations are strictly studied and documented. With the principle of "providing the best-in-class quality to and serving for the interests of customers", GenScript is committed to helping customers shorten the timeline for biological drugs from development to clinical use, significantly cutting the R&D costs, accelerating the commercialization of medicines, and building a healthy future while making contributions to the development of the pharmaceutical industry under the Made in China 2025 plan.
Advertisement
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.
Advertisement
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.
Dr. He gave a speech during the ceremony, during which he emphasized: "Cell therapy products are 'live' medicines, and the manufacturing of high-quality and cGMP-compliant plasmid and viral vectors is one of the most critical components in the commercialization of cell and gene therapies. Legend Biotech has established a global presence in terms of commercial production. Our commercial manufacturing facility in the US will soon become operational. In our home market of China, we will work closely with GenScript's CDMO facility to facilitate commercialization of plasmid and viral vectors as well as cell production."
Ye Shengqin, Chairman of Shanghai Longyao Biotechnology Inc.,Ltd, said: "Partnerships are an important contributor to the development of innovative-oriented firms. As a strategic partner of GenScript, Shanghai Longyao Biotechnology Inc.,Ltd has awarded its CDMO business consisting of plasmid and viral preparations of two new CAR-T products featuring distinctive technology benefits to GenScript. Our collaboration is under way as planned. I believe this is only the beginning of our increasingly enhanced partnership."
Dr. Brian added: "Since its foray into the CDMO market, GenScript has grown rapidly. After successfully applying for Legend Biotech's CAR-T project, we have been awarded several IND application projects as well as ones involving plasmid and virus production, including CAR-T, UCAR-T, TCR-T and AAV gene therapy projects. In order to provide a turnkey service for the commercialization of gene and cell therapy products, GenScript planned the Manufacturing Center. As for antibody drugs, Zhenjiang's GMP facilities will meet the needs for Phase III clinical sample and commercial production. We believe that our efforts will enhance China's advantages in the development of biologics and accelerate the development of the country's pharmaceutical industry."
About GenScript
GenScript Biotech Corp is a leading Chinese bio-pharmaceutical contract development and manufacturing organization (CDMO), with extensive services in gene synthesis, peptide synthesis, antibody development, protein expression and custom biological reagents as well as providing a one-stop biological drug research and development platform. GenScript's one-stop antibody drug development solutions include antibody drug discovery (hybridoma, phage display, full human and bispecific antibodies technologies), antibody engineering (antibody humanization, evaluation and optimization of drug compounds and affinity maturation) and other services. GenScript's total cell therapy solution covers IND preparation as well as clinical sample and commercial production. Process development controls ensure compliance, data integrity ensures traceability, and all test deviations are strictly studied and documented. With the principle of "providing the best-in-class quality to and serving for the interests of customers", GenScript is committed to helping customers shorten the timeline for biological drugs from development to clinical use, significantly cutting the R&D costs, accelerating the commercialization of medicines, and building a healthy future while making contributions to the development of the pharmaceutical industry under the Made in China 2025 plan.
View original content:http://www.prnewswire.com/news-releases/chinese-cdmo-genscript-starts-construction-of-genscript-legend-biotech-commercial-manufacturing-center-300831894.html
SOURCE GenScript Biotech Corp
