この施設はカリフォルニア州サンフランシスコに位置し、44,000平方フィートの最先端の環境で、細胞療法プロセス・分析開発、細胞治療の開発から商業生産までのエンドーツーエンドのcGMP製造サービスを国内および世界中の顧客に提供しています提供しています。サンフランシスコ国際空港からわずか15分という便利な立地にあり、地域の主要な病院にも近接しています。
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Fact Sheet
Cell therapy manufacturing solutions fact sheet
The cell and gene therapy market is experiencing accelerated market approval opportunities, record breaking investments, robust therapeutic pipelines, and positive clinical outcomes – all driving the need for speed, regulatory know-how, and innovation in manufacturing technologies.
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Optimizing the cell therapy patient journey through integrated CRO CDMO partnership
Watch this on-demand webinar for insights on how working with a single integrated CRO/CDMO partner can help ease industry challenges and provide an accelerated path from development to manufacturing, as well as the benefits that come from unified teams and infrastructure.
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Autologous and allogeneic therapies - today and tomorrow: Exploring the science, manufacturing and regulatory considerations
In this roundtable discussion, clinical and commercial experts address the complex dynamics associated with allogeneic vs. autologous cell therapies and offer insight into the current and future state of the industry. Specific topics include best practices for manufacturing and logistics, regulatory landscape and CMC requirements, and the role of standardization.
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Cell therapy manufacturing workflow
View our new infographic for an overview of a genetically modified cell therapy workflow and the key considerations at each step, ranging from plasmid production through cold chain logistics.
eBook
Cell and gene therapies in the US vs. the EU: Top five areas of differentiation
In this eBook we share the five key differences in the drug development and review process for companies hoping to gain market access through US Food and Drug Administration (FDA) or European Medicines Agency (EMA) approval—as well as tips for navigating these differences.
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Key considerations when selecting a CDMO partner for cell therapy manufacturing
Like many therapeutic manufacturing workflows, every step in the mRNA process builds upon the prior step. This infographic explores each intertwined step in the mRNA manufacturing process and outlines how Thermo Fisher Scientific’s flexible approach can get your mRNA product to clinic and market faster.
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