Advanced Therapies

End-to-end advanced therapy development and manufacturing services

Advanced therapeutics, such as cell and gene therapies, have the immense potential to revolutionize healthcare. However, the path from translational studies to clinical trials and commercial manufacturing is riddled with challenges and risks. Therefore, it’s essential to partner with a CDMO with the experience, capacity, network, and ability to adapt and personalize its approach. With our extensive expertise, end-to-end services, and robust global supply network, we can effectively help biotechnology and pharmaceutical companies navigate the journey from molecule to medicine. Our portfolio of capabilities is equipped to handle your unique needs and empowers you to confidently meet critical timelines and bring your therapy to market, transforming lives worldwide.

20+ years of GMP manufacturing experience

Proven expertise in process and analytical development, clinical and commercial manufacturing

700+ viral vector lots

700+ viral vector GMP clinical and commercial/PPQ lots manufactured in NA and Europe

15+ facilities worldwide

Our global network of facilities can support advanced therapy projects of any scope

Advanced therapy CDMO services, solutions, and capabilities

Thermo Fisher Scientific’s viral vector services team has unparalleled experience and a proven track record of manufacturing GMP viral vector products to support cell and gene therapies for more than 20 years, including AAV, adenovirus, lentivirus, HSV, retrovirus, and others. Our end-to-end solutions encompass process and analytical method development, scale-up to GMP for clinical or commercial manufacturing (50–2,000 L), and sterile fill-finish capabilities.

  • 20+ years of viral vector experience
  • 700+ viral vector GMP clinical and commercial/PPQ lots manufactured in NA and Europe
  • 160+ viral vector products produced
  • 2 commercial-use license obtained (and several others pending)

We provide a foundation of support systems and technical expertise in a variety of modalities, including autologous and allogeneic therapies leveraging both modified (viral or nonviral) and non-modified manufacturing processes for immune (T, NK) and stem (iPSC, MSC, and HSC) cells. Our approach to manufacturing readiness balances the need for speed with an unwavering focus on quality, while individual, user-configurable suites ensure long-term scalability as you move toward commercialization.

Thermo Fisher Scientific has responded quickly to increased demand for mRNA technology by ramping up an end-to-end service model inclusive of process and analytical development, cGMP manufacturing for mRNA synthesis and lipid nanoparticle (LNP), sterile fill and finish, and cold chain logistics. We are well-suited to support your complex and unique cGMP mRNA manufacturing needs, with flexibility to address both smaller volume requests and larger projects up to 100 g. Leverage the full suite of integrated services or just choose those that help fill immediate gaps in your capabilities or capacity.

The services encompass generation of relevant materials as well as consulting support tailored for the translational phase of advanced therapy development. We specialize in producing high quality small-scale plasmid DNA, viral vector, and cell therapies through employing scaled-down processes that mimic cGMP workflows. This approach effectively mitigates risks and facilitates a seamless transition from initial discovery to clinical research, and ultimately commercialization.

With our global network of biorepositories, integrated quality systems, and experience maintaining the integrity of millions of samples, we can store, process, and transport specialized cell and gene therapies worldwide under ambient to cryogenic temperatures. Our capabilities enable customers to seamlessly conduct clinical trials across multiple geographies while providing patients around the world access to life-changing therapies.

Global cell and gene therapy clinical supply support

As the leading service provider in the cell and gene therapy community, we’re uniquely positioned with the experience, resources, and global expertise to support our customers on their path from development to commercialization.

Specific advanced therapy supply chain solutions include:

  • GMP biologics management and storage
  • Cold chain logistics and distribution
  • Clinical site and specialty courier services
  • Continuous monitoring for cryogenic shipments
  • Comprehensive chain of custody and identification capabilities (inclusive of serialization)
  • Secondary packaging and labeling
  • Kit production

Featured advanced therapy resources

Advanced therapy resource library

Explore a wealth of advanced therapy resources, including trend-focused blogs, technical webinars, informative videos, and insightful infographics on mRNA, viral vectors, and cell therapy CDMO services.

Collaboration and support, from development to commercialization

We know you have questions about your advanced therapy’s development and commercialization, such as: “How to generate materials for translational studies?”, “What’s the right level of data for IND filing?”, “How can I scale up my project?”, “How to navigate complex regulatory pathways?”, and “What’s the impact on the supply chain?” We can help accelerate your advanced therapy’s development and commercialization journey through our end-to-end solutions, industry expertise, and innovative technology.