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Meets all U.S., EU and Chinese GMP requirements
July 19, 2019
By: Tim Wright
Editor-in-Chief, Contract Pharma
GenScript Biotech Corp., a biologics contract development and manufacturing organization (CDMOs) in China, said its biologics research and development (R&D) and production center was formally put into operation on July 11, 2019. This represents another milestone for the firm following the groundbreaking ceremony of its commercial manufacturing center in Zhenjiang, Jiangsu province. Construction of the Nanjing-based, 9,300-square-meter biologics R&D and production center was completed in June 2019. Design and infrastucture of all facilities meet all U.S., EU and Chinese GMP requirements. Once put into production, the center is expected to meet the production needs of all types and quantities of pre-clinical and phase I clinical samples. He Tao, deputy director of the management committee of the Jiangning District was invited to the opening ceremony and delivered a speech during which he said, “Biologics is an important industry for the national economy and people’s livelihood. Over the recent years, GenScript Biotech has witnessed rapid growth, which is the first step in the firm’s larger expansion. We believe that the firm will become a strong driver of Nanjing’s pharmaceutical industry.” Brian Min, chief executive of the biologics business at GenScript Biotech, said, “We are very glad to be celebrating the opening of our first biologics R&D and production center. We have 17 years of experience in biologics research and development. At the beginning of 2019, we established a foothold in the biologics sector as an independent business. Our team is now growing rapidly. GenScript’s planned biologics commercial production center will be the first and largest such facility in China covering cell therapy, gene therapy and antibody drug R&D. We will be able to meet the rapidly evolving demands of gene and cell and antibody and protein therapies.” Deng Liang, senior R&D director, Betta Pharmaceuticals, a key GenScript partner, said, “With growth of the firm going back more than a decade, GenScript has been a leader in the global biological reagent service industry, having a large number of high-level talents and the leading Biologics CDMO platform. The opening of GenScript biologics R&D and production center not only represents a major milestone in the firm’s history, but also sets an example for the construction of a macromolecular biologics GMP production workshop in China.” GenScript’s biologics GMP production center in Nanjing is scheduled to be put into production in 2020, with an accumulated production capacity of up to 2,600L, meeting the production needs for samples in Phase I and II clinical stages. Phase I of the planned 150,000-square-meter clinical and commercial production center in Zhenjiang is now under construction. Once completed, the center will have an accumulated production capacity of 47,600L, becoming the first and largest biologics commercial production center covering cell therapy, gene therapy and antibody R&D in China, meeting customers’ demands for commercial production of samples.
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