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The company has launched new services for mammalian cell bank manufacturing under GMP conditions.
Sartorius Stedim Biotech (SSB), a supplier of biopharmaceutical manufacturing products and services, announced the launch of new services for mammalian cell bank manufacture under GMP conditions on Aug. 8, 2019. The company will offer these services through its subsidiary, Sartorius Stedim BioOutsource, a contract testing organization based in Glasgow, UK, and in Cambridge, MA, in the United States.
Based on these new services, SSB can now offer the manufacture of GMP master and working cell banks (MCB/WCB) for mammalian suspension cells, which will be conducted in a custom-designed 260-m2 GMP cleanroom facility that has been audited and approved in 2018, according to the latest guidelines by the Medicine and Healthcare Products Regulatory Agency (MHRA). The facility is exclusively dedicated to mammalian suspension cell lines and uses selected equipment that enables closed-system manufacture of GMP-compliant cell banks, from vial thaw to automated filling. The entire manufacturing service is offered as a fully qualified broth technology platform, which is expected to maximize process reliability and assurance of sterility.
The GMP manufacture of master cell banks is a critical step during the development of biopharmaceutical drugs where time is always key. To ensure the best possible timelines, the company’s cell bank manufacturing is offered in a package along with cell bank characterization services that has been provided for more than ten years. The combination of its new manufacturing services and its established characterization service for mammalian cell banks makes SSB a single-source provider from vial thaw to released cell banks.
Up to 500 cell bank vials are produced during a manufacturing run, followed by full characterization, genetic stability assessment in compliance with European Union and FDA guidelines, and release by the respective qualified person. The cell bank vials produced are then shipped to the client or transferred to a long-term storage facility. In addition, these cell bank manufacturing and characterization services match the company’s cell line development services based on Sartorius Stedim Cellca’s Chinese hamster ovary (CHO) expression platform. SSB can now offer all three services combined-cell-line development, cell bank manufacturing, and cell bank characterization-giving the company the ability to provide biomanufacturing solutions from DNA to released GMP cell bank within a 10-month timeline.
“We’re really proud that we now offer even more comprehensive services that can be easily combined with those for CHO cell-line development and biosafety. As a result, we provide our clients with an integrated package that saves considerable time and minimizes risks. Furthermore, they will benefit from client-focused customer service with a single point of contact throughout their entire development and manufacturing projects,” stated Lucia Rieger, product manager for protein expression systems, SSB, in a company press release.
Source: Sartorius Stedim Biotech