Wednesday, 18 September 2019

GenScript Biotech starts operations for Biologics R&D and production center

19 July 2019 | News

Biologics commercial production centre will be the first and largest such facility in China covering cell therapy, gene therapy and antibody-drug R&D to meet the production needs of pre-clinical and phase I clinical samples

image credit- shuttershock.com

image credit- shuttershock.com

GenScript Biotech Corp., one of the leading Biologics contract development and manufacturing organizations (CDMOs) in Nanjing, China, on 17 June 2019, announced that its Biologics research and development (R&D) and production center was formally put into operation on 11 July 2019. This represents another milestone for the firm following the groundbreaking ceremony of its commercial manufacturing center in Zhenjiang, Jiangsu province. Government leaders, experts in the Biologics sector, representatives from China's leading and most innovative companies, investors dedicated to the innovation in the pharmaceutical space, and industry journalists witnessed this landmark moment.

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 US, 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.

GenScript Biotech, which has received the full support of the government of Jiangning District, has already had a significant positive impact on Nanjing as it continues to grow rapidly. He Tao, deputy director of the management committee of the district said, "Biologicsis 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."

Dr Brian Min, CEO 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. Based on GenScript's mission of 'offering customers the best quality', GenScript remains focused on accelerating our innovative drug development process through the most advanced platform and flexible business model. We are looking forward to bringing a brighter future to patients worldwide through drug development."

Dr. Deng Liang, senior R&D director of 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."

Following the opening ceremony, guests visited the Biologics R&D and production center. Once fully put into production, the center will realize a complete end-to-end whole supply chain system, from pre-clinical research, clinical trial and commercial production to R&D, procurement and production. The center will provide more efficient and flexible R&D and production services for domestic and foreign partners.

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 2,600 L, 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 47,600 L, 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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