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实例探究 > Sartorius Accelerates Cell Line and Process Development by a Factor of 3

Sartorius Accelerates Cell Line and Process Development by a Factor of 3

技术
  • 应用基础设施与中间件 - 数据交换与集成
  • 平台即服务 (PaaS) - 数据管理平台
适用行业
  • 医疗保健和医院
  • 药品
适用功能
  • 产品研发
  • 质量保证
用例
  • 库存管理
  • 预测性维护
  • 过程控制与优化
服务
  • 数据科学服务
  • 系统集成
挑战
Sartorius Stedim Biotech, a leading provider of instruments, technologies, and expertise for the development and production of biopharmaceuticals, was facing a major data processing bottleneck due to its rapid growth. The company was primarily using Excel and paper for data management, which became increasingly challenging as the number of cell lines they were handling per year grew. The manual integration and correlation of data for in-project and cross-project analyses were extremely labor-intensive and time-consuming. Sartorius needed a central platform to streamline and digitalize cell line and process development, expand automation, and improve throughput and efficiency. They were looking for a solution that could handle their specific workflow requirements, automate laboratory operations, enable a transition to a fully paperless laboratory, and enhance scalability to support their continued growth.
关于客户
Sartorius Stedim Biotech is a leading global technology provider and Contract Development & Manufacturing Organization (CDMO) for the biopharmaceutical industry. The company provides cell lines, cell banks, and bioanalytical services. Sartorius' solutions are used by biopharma and biotech companies to safely and economically develop and produce innovative drugs. In 2015, Sartorius expanded their bioprocess development portfolio to include cell line development and upstream and downstream process development services for large-scale protein production of biopharmaceuticals in mammalian cells (CHO). They support their customers in the development of processes for the production of mAbs, bispecific antibodies, Fc-fusion proteins, enzymes, vaccines, and biosimilars. More recently, Sartorius has rapidly expanded into the cell & gene therapy (CGT) and the mRNA markets.
解决方案
Sartorius chose to implement the Genedata Bioprocess enterprise workflow platform as it met all their requirements and was the only commercial-off-the-shelf (COTS) solution that included all required logic. The platform was able to be directly integrated into Sartorius' wide array of laboratory equipment, facilitating seamless transfer of data and samples along the full development workflow. The Genedata platform seamlessly interacts with Sartorius’ screening robotics systems, bioreactors such as ambr15 and ambr250, BioStats, as well as analytics devices such as Octet. Today, Genedata Bioprocess is the digital workflow backbone of Sartorius’ quickly growing cell line and process development organization. It supports Sartorius’ unique and proprietary processes including CHO transfections, expression vectors, plasmid generation and optimization, media development, and tailored upstream process design workflows.
运营影响
  • With Genedata Bioprocess in place, Sartorius has significantly increased operational efficiency and reduced costs. The platform is used in the daily operations of all cell line and process development teams to monitor and assess key process and quality parameters such as confluence, titers, monoclonality, and viable cell density.
  • By providing project progress tracking in real-time, Sartorius can now seamlessly and continuously monitor all resources across cell line and process development projects, enabling systematic resource planning and streamlining operations.
  • The Genedata platform has also increased process quality. By automating data transfer and documentation of critical data, Sartorius has minimized errors and ensured data integrity.
数量效益
  • Sartorius has been able to triple their productivity.
  • A Sartorius-internal assessment showed that the time saved having central access to digital documentation is more than 30%.

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