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INDUSTRY NEWS AND PRESS RELEASES |
Sartorius Stedim Biotech Launches New Services for Mammalian Cell Bank Manufacturing |
Sartorius Stedim Biotech |
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Integrated package of new and established services saves time and minimizes risks
Based on these new services, Sartorius Stedim Biotech 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. Exclusively dedicated to mammalian suspension cell lines, the facility 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.
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, Sartorius Stedim Biotech 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. With all three services combined – cell line development, cell bank manufacturing, and cell bank characterization – Sartorius Stedim Biotech supports clients as a total solutions provider 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.
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News and Press Releases |
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Exogene Raises $2 million for its AI platform to Discover Cell Therapies for Cancer
Oxford, UK, 25th April 2022 / Sciad Newswire / Exogene, a biotech
company discovering novel T-cell receptor-based cell therapies, today
announces that it has raised US$2 million in funding to develop its
artificial intelligence (AI) platform for T-cell receptor discovery.
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White Papers |
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Investigator Portals: Facilitating and Streamlining Communication & Collaboration with Study Sites
ArisGlobal
ArisGlobal LLC
Investigator site personnel are often frustrated with the lack of transparency and communication with their sponsors, leading to significant dissatisfaction and withdrawal from current and future studies. The adoption of investigator portals gives sponsors a platform that fosters collaboration and improves site management. Learn about five key areas of sponsor-investigator site interactions deserving of electronic communication and collaboration. Technology and design aspects are also covered.
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Industry Events |
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Pharmaceutical Manufacturing & Packaging Congress (PHARMAP 2022)
20-21 June 2022, Berlin, Germany
Pharmaceutical Manufacturing & Packaging Congress (PHARMAP 2022) is
held on June, 20-21, 2022 in Berlin, Germany. The Congress gathers
pharmaceutical companies, CMOs and CDMOs, governmental bodies together
with pharmaceutical equipment providers and service companies to discuss
the manufacturing and packaging processes of the pharmaceutical
industry. Among the participating companies are Bayer, Sandoz, Merck,
Novartis, Roche, Genveon, Samsung Biologics, Pfizer.
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