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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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PCI Strengthens Position in Europe with Investment in Ireland
Philadelphia, PA – August 27, 2019 – PCI Pharma Services (PCI), a leading biopharmaceutical outsourcing services provider, has solidified its leadership position in the EU with strategic investment to deepen its presence in Ireland and expand its European foothold.
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White Papers |
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The Impact of Components on Drug Quality and Risk Mitigation
West Pharmaceutical Services, Inc.
Expectations for quality by regulatory agencies are increasing at a very fast pace, especially for prefilled drug delivery formats, thanks to increased focus on reducing risk to patient safety. The trend has resulted in delays for new drug applications, more recalls of marketed products and even drug shortages if the container system and drug contents are suspect for quality issues. The pharmaceutical market is now requiring manufacturers of containers and components to meet new expectations with a quality culture and very high product reliability. The need to bridge the gap and provide superior quality products has been a driver for manufacturing technology investments, more robust control strategies and the introduction of next generation elastomer components.
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Industry Events |
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ESMO Targeted Anticancer Therapies Congress 2020
2-4 March 2020, Paris, France
A unique and international mix of experts, researchers and decision
makers both from academia and industry across the globe, will convene
in Paris for a three-day Congress aiming at exchanging knowledge,
experience and research innovations in cancer.
TAT
2020 will focus, among others, on novel strategies in immuno-oncology,
personalised medicine and molecular tumour boards, preclinical studies
to identify effective combination therapies, use of microbiome, tumour
agnostic trials, ADC technology, oncolytics, multispecific biological
constructs and targeting cytokines.
Participating in TAT 2020 will offer you the possibility to take part in
interdisciplinary discussions inspiring new ideas and new
collaborations.
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