San Francisco, California, USA
Cell therapy development and manufacturing facility
Located adjacent to numerous oncology hospitals in the Bay Area and approximately 15 minutes from the San Francisco International Airport, this 44,000 sq. ft., state-of-the-art facility provides full-service cell therapy process and analytical development capabilities and clinical and commercial cGMP manufacturing services to customers across the US and globally. Our team has experience in a variety of modalities including autologous and allogeneic cell therapies, viral and non-viral modified gene delivery systems, and numerous cell types (T-cells, NK cells, iPSCs, MSCs, and more).
Capabilities
- Cell isolation, modification, expansion, fill-finish, and cryopreservation
- AD/PD lab for process optimization, verification, and confirmation, as well as method development/qualification and assay optimization
- QC lab to support in-process, safety, and final product testing
- Individual, user-configurable production suites with self-contained HVAC and related infrastructure to protect against cross-contamination
- Collaboration center to provide non-GMP space for training scientists and operators both for tech transfer and process development
- Support for phase I through commercial manufacturing
- Potential to expand based on customer needs
Helpful Resources
Fact Sheet
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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Webinar
Webinar
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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Video
Video
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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Infographic
Infographic
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
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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Webinar
Webinar
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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