Sartorius Stedim Biotech (SSB) launched new services for mammalian cell bank manufacture under GMP conditions. These services are offered by its subsidiary, Sartorius Stedim BioOutsource, based in Glasgow, U.K., and Cambridge, MA.
Based on these new services, SSB now offers the manufacture of GMP master and working cell banks (MCB/WCB) for mammalian suspension cells. This activity will be conducted in a custom-designed 260 m2 GMP cleanroom facility that has been audited and approved in 2018 by the Medicine and Healthcare Products Regulatory Agency (MHRA) according to the latest guidelines, noted a Sartorius spokesperson.
Exclusively dedicated to mammalian suspension cell lines, the facility reportedly uses selected equipment that enables closed-system manufacture of GMP-compliant cell banks, from vial thaw to automated filling. For maximum process reliability and assurance of sterility, this entire manufacturing service is offered as a fully qualified broth technology platform, explained Lucia Rieger, product manager for protein expression systems.
SSB’s cell bank manufacturing is offered in a package along with cell bank characterization services that the company has been providing for more than ten years. The combination of its new manufacturing services and its established characterization service for mammalian cell banks allows clients to work with SSB as 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 EU 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 are a “perfect match” for the cell line development services based on Sartorius Stedim Cellca’s CHO expression platform, said Rieger.
“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,” added Rieger.