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
900+ viral vector lots
900+ viral vector lots manufactured, including GMP clinical and commercial lots over time
13+ facilities worldwide
Our global network of facilities can support advanced therapy projects of any scope
The value of a strategic CDMO partnership
At Thermo Fisher Scientific, we focus on understanding the unique needs of your advanced therapy so that we can innovate tailored solutions to meet them. Leveraging our extensive experience as a pharma services provider, combined with access to products and tools that enable innovation, we provide you with the complete capability and adaptability needed to chart your own path with confidence.
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.
To support the increasing number of clinical applications for mRNA technology, we offer a flexible end-to-end service model inclusive of process and analytical development, cGMP manufacturing for mRNA synthesis and lipid nanoparticle (LNP), sterile fill-finish, and cold chain logistics. Our team is equipped to meet your complex and unique mRNA manufacturing needs, with flexibility to address both small 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.
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. 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
Meet our team of advanced therapies experts
Andrene Gordon
Process Development Manager, Viral Vector Services
Pouria Motevalian
Director of Bioprocess Sciences, Viral Vector Services
Collaboration and support, from development to commercialization
Our team of experts are available to answer any questions you have 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?
- 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.
Featured advanced therapy resources
Explore a wealth of advanced therapy resources, including trend-focused blogs and articles, technical webinars and whitepapers, informative videos, and insightful infographics on mRNA, viral vector, and cell therapy related topics.