Sartorius Stedim Cellca社、Genedata Bioprocessを導入：
バイオ医薬品CRO/CMO Sartorius Stedim Cellca社、ドイツ・イギリス・アメリカ・韓国の研究所にGenedata Bioprocessを導入し、タンパク質大量生産用の細胞株構築および培養プロセス開発データ管理に活用
November 6, 2018
Genedata, a leading provider of advanced software solutions for biopharma R&D, today announced that Sartorius Stedim Cellca GmbH, a subsidiary of Sartorius Stedim Biotech (SSB) and a specialist for cell line development and bioanalytical services for large-scale protein production, has licensed the Genedata Bioprocess® enterprise platform to be used at SSB laboratories in Germany, the U.K., the U.S., and South Korea. Genedata Bioprocess is expected to further increase effectiveness and experimental throughput of biotherapeutics CRO and CMO operations.
“We aimed to extend automation and further enhance the efficiency of our cell line, upstream and bioanalytical development operations, and quickly realized that Genedata Bioprocess addresses many of our requirements off-the-shelf, eliminating the need for expensive customization. We therefore decided to implement Genedata Bioprocess across our development operations,” said Hugo de Wit, Managing Director at Sartorius Stedim Cellca and Sartorius Stedim BioOutsource. “We were also intrigued with the platform’s capability to be directly integrated into our wide array of laboratory equipment and with the way this would facilitate seamless transfer of data and samples along the full development workflow,” continued de Wit.
The enterprise platform will be used to manage diverse workflows and laboratory operations for the full Sartorius Stedim Cellca solution portfolio, helping its customers develop mAbs, Fc-fusion proteins, Fab-related products, bispecific antibodies, and biosimilars. In particular, the platform will support Sartorius Stedim Cellca’s unique cell line development process, consisting of proprietary expression vectors, host cell lines, CHO media systems and a tailored upstream process design. This will result in high yield, stable cell lines and robust, simple, easy-to-scale fed-batch processes, plus research cell banks (RCBs) and master cell banks (MCB). Customers stand to benefit from the efficiency of bioanalytical testing services provided by Sartorius Stedim Cellca and Sartorius Stedim BioOutsource based on simplified processes and even faster timelines.
“We are excited to collaborate with Sartorius Stedim Cellca, a leader in the CRO and CMO market for cell line and process development. Due to its global reach and excellent reputation, Sartorius Stedim Cellca is an ideal partner for Genedata,” said Dr. Othmar Pfannes, CEO of Genedata. “We strive to offer fully integrated solutions that reduce development time and costs, making both innovator drugs as well as biosimilars more affordable. We will continue to develop our biopharma platform to further automate and simplify bioprocess development operations.”
The Genedata Bioprocess software solution enables fully integrated workflow management for large-molecule development and CMC operations. As an enterprise-wide data backbone, it supports the full E2E workflow – ranging from developing cell lines and upstream processes (USP) to downstream processes (DSP), as well as formulation and analytics. Genedata Bioprocess has been co-developed with major biopharmaceutical companies over the past five years.
About Sartorius Stedim Biotech
Sartorius Stedim Biotech is a leading international partner of the biopharmaceutical industry. As a total solutions provider, the company helps its customers to manufacture biotech medications safely, rapidly and economically. Headquartered in Aubagne, France, Sartorius Stedim Biotech is quoted on the Eurolist of Euronext Paris. With its own manufacturing and R&D sites in Europe, North America and Asia and an international network of sales companies, Sartorius Stedim Biotech has a global reach. The Group has been annually growing by double digits on average and has been regularly expanding its portfolio by acquisitions of complementary technologies. In 2017, Sartorius Stedim Biotech employed approx. 5,100 people and earned sales revenue of €1,081.0 million.