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
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
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.
Our flexible service offering supports a range of plasmid application areas, including starting material for viral vector manufacturing, plasmid as a drug substance, and linearized plasmid DNA for mRNA synthesis. Additionally, a phase-appropriate approach to service provides access to full cGMP quality plasmid material regardless of clinical phase of use, with the option to enhance service with additional traceability and/or customized documentation as needed.
Streamline your translational research to rapidly identify lead therapeutic drug candidates by leveraging high quality material to generate reliable proof-of-concept data. Due to the complexity of viral vector production, inherent challenges persist with establishing and maintaining product consistency throughout development phases. By including appropriate manufacturing and raw material controls during discovery, lead candidates have a strong potential to quickly and easily translate from discovery through preclinical and cGMP manufacturing.
Patheon Translational Services include custom molecular biology (cloning, plasmid DNA constructs), viral vector packaging (Lentivirus [LV], adeno-associated virus [AAV]), and cell therapy services that use established scalable processes with advanced analytical testing representative of future cGMP workflows. Leverage an experienced team of scientists with over 20 years of cGMP manufacturing and technical experience to accelerate product development and facilitate a smooth transition to the clinic.
Molecular biology services options
- In silico analysis (e.g., codon optimization, construct design)
- Cloning (e.g., de novo synthesis, antibiotics resistance cassette swapping, cut-n-paste fragments)
- Plasmid expansion
Viral vector packaging services options
- Customized LV and AAV packaging using suspension, serum-free, triple plasmid transfection in HEK293F-derived cells
- Affinity-based purification method
- Suitable for in vitro and in vivo applications
Additional services available upon request, including analytical testing.
Experience the benefits of Patheon Translational Services:
- Accelerate timelines and de-risk translating to cGMP manufacturing with minimal bridging studies
- High throughput production capacity using scale-down manufacturing processes
- Qualifiable, best-in-class analytical tests
- Well documented cell line lineage and clonality to enable tech transfer
- Optimized for seamless portability into Patheon cGMP manufacturing platforms including Quick to Clinic™ viral vector services, Quick to Care™ services for advanced therapies, or standard process development and manufacturing
- Experienced scientific and regulatory teams who have successfully taken drugs from process development to market
Translational Services generates materials for research use only. Not for IND-enabling studies or diagnostics purposes.
Helpful resources
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
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.
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 post
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.
Read blog
Webinar
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.
Watch webinarAdvanced 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, cell therapies, and plasmid DNA 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.