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.
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 non-viral) and non-modified manufacturing processes for a variety of cell types (T-cells, NK cells, iPSCs, MSCs, APCs, hESCs, blood and bone marrow-derived stem cells and more). 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.
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.
Our translational research 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. 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
Dan Herring
General Manager, Advanced Therapies
Aditi Thakkar
Cell Therapy Process Development Scientist
Shivangi Sachdeva
Cell Therapy Analytical Development Scientist
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.
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.
View eBook
Video
Autologous and allogenic therapies - today and tomorrow
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.
Blog
Delivering on the promise of cell and gene therapies: A patient-centric approach
In this session, you will gain insights into the complexities of the CGT ecosystem and the challenges that must be overcome to successfully move CGT therapeutics from the laboratory to the patient.
Blog
Flexible regulatory pathways and key CMC considerations to commercialize cell and gene therapy products
This webinar will provide key advice for determining and navigating the regulatory pathway for any cell and gene therapy.