While cell therapies offer an exciting new treatment paradigm for patients, there are many complex factors that may limit their commercial success, including analytics, scalability, regulatory hurdles, and more. At Thermo Fisher Scientific, we recognize the importance of an individualized approach for cell therapy projects to help navigate these challenges together. As a full-service cell therapy CDMO partner, we provide process and analytical development and cGMP manufacturing to support customers from clinical through commercial phases.
We offer a foundation of support systems and technical expertise in a variety of modalities, including:
As part of Patheon pharma services, we’ve been active in pharmaceutical manufacturing for more than 20 years and have the expertise and flexibility you need to continue moving at a rapid pace. Our approach to manufacturing readiness balances the need for speed with an unwavering focus on quality and innovation. Additionally, our user-configurable suites at our state-of-the-art facility in San Francisco, CA ensure long-term scalability as you move toward commercialization. By leveraging a “just-in-time” strategy for facility buildout, we work diligently to advance your unique space from concept to facility at a rapid pace to meet your project timelines.
In addition to core cell therapy manufacturing services, we also provide upstream and downstream offerings to support all aspects of your development journey. From early translational services to help optimize your process at a small scale, to cold chain logistics to facilitate secure storage and distribution of your final product, we’re a one-stop solution for managing your unique cell therapy project needs.
The regulatory landscape for advanced therapies is constantly evolving, and what’s acceptable today may not be adequate tomorrow. For over 15 years we have supported customers with global regulatory interactions (US, EU, and Canada), CMC regulations, guidelines, and inspections. In addition to providing document reviews and gap analyses, our regulatory services team can generate documents to reduce the number of intermediaries and lead times in preparing regulatory filings.
Cell and gene therapy 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.View Fact Sheet
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.Watch Webinar
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.Watch Video
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.
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.View eBook
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.Watch Webinar