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Lentiviral (LV) vector manufacturing services
More than a CDMO: An ecosystem of services and scientific advisors you can trust
From early process development through commercial GMP manufacturing, Thermo Fisher Scientific serves as your trusted scientific advisor and strategic development partner, combining proven lentiviral vector manufacturing expertise with the capabilities of our global network to help solve complex challenges and accelerate your path to patients.
With experience supporting CAR-T therapies, ex vivo and in vivo gene therapy applications, multiple manufacturing platforms, and commercially approved products, we provide the technical expertise and manufacturing flexibility needed to navigate today’s evolving landscape—and the scientific knowledge to help you prepare for tomorrow’s innovations.
2 commercially approved lentiviral vector products
590+ total GMP manufacturing batches
70+ clinical manufacturing batches
510+ commercial and PPQ batches
Extensive experience supporting global regulatory submissions
Your trusted advisor with comprehensive CDMO services
Our viral vector experts combine scientific insight with proven manufacturing experience to help you make confident, strategic decisions from development through commercial manufacturing. Explore our services:
- Extensive experience with CAR-T and other cell therapy programs
- Ex-vivo and in-vivo applications
- Expertise with multiple pseudotypes
- Flexible development and manufacturing models
- Transient transfection expertise
- Adherent manufacturing: Flatware and fixed-bed bioreactors
- Suspension manufacturing: Stirred-tank bioreactors from 50 L to 2,000 L
- Method development and validation
- Vector characterization
- Potency, identity, purity, and safety testing
- Data-driven insights to support critical decisions
- Comprehensive testing and release
- In-process and final product testing
- Advanced assays and state-of-the-art laboratories
- Commitment to product quality and safety
- Clarification
- Purification
- Concentration
- Formulation
- Robust quality systems
- Risk-based approach
- GMP compliance and regulatory readiness
- Continuous improvement
- Aseptic processing in GMP suites
- Crystal Zenith, glass, and bag options
- Labeling and packaging
- Scalable solutions from clincial through commercial
- Capacity for up to 10,000 vials
- Plasmid sourcing and procurement
- Vendor management and qualification
- Supply coordination and logistics
- Quality oversight and documentation
New lentiviral manufacturing services
New cell line for lentiviral manufacturing
Thermo Fisher Scientific now offers a new cell line, HEK293T, for lentiviral manufacturing. This cell line has been adapted to be a suspension cell line with a T-antigen receptor, helping to increase titer levels for efficient cell therapy production.
New plasmid management services
Our new plasmid management service simplifies transient transfection programs by coordinating plasmid sourcing on your behalf. Rather than managing multiple vendors independently, we will coordinate plasmid procurement, scheduling, quality oversight, and manufacturing readiness for you.
Advance your LV program with our Rapid Development Framework™
Our Rapid Development Framework™ is a flexible development solution for transfection-based lentiviral vector manufacturing that combines proven processes, established analytics, and configurable workflows to help accelerate your path from development to GMP manufacturing.
Through our Rapid Development Framework™, you benefit from:
- Proven upstream and downstream process workflows
- Established analytical methods and platform testing
- Pre-qualified raw materials and manufacturing components
- High-throughput process development and optimization
- Dedicated project management backed by Thermo Fisher's global scientific network
- Flexible process customization to meet product-specific requirements
- A streamlined transition from development to GMP manufacturing
Why choose the Rapid Development Framework™?
Our framework is designed to help you:
- Accelerate process development
- Reduce technical and manufacturing risk
- Enable efficient process scale-up
- Improve consistency through standardized processes and analytics
- Streamline technology transfer and support regulatory readiness
- Progress from development to clinical and commercial manufacturing faster
- GMP filled drug product in as little as 9 months* for applicable viral vector programs
Why leading cell and gene therapy developers partner with us
As a trusted drug development and manufacturing partner, Thermo Fisher Scientific helps cell and gene therapy innovators from across the world navigate the complexities of lentiviral vector development with confidence.
Our integrated capabilities—from process development and analytical expertise to GMP manufacturing and sterile fill-finish—provide a seamless pathway from early development through commercialization.
Backed by proven manufacturing experience and dedicated scientific teams, we work collaboratively to help reduce development risk, streamline technology transfer, and deliver scalable solutions tailored to your program.
Frequently asked questions about lentiviral vector services
We provide integrated lentiviral vector manufacturing services including process development, transient transfection, adherent and suspension manufacturing, downstream purification, analytical development, GMP manufacturing, technology transfer, plasmid management, and commercial manufacturing support.
Yes. Our teams have extensive experience supporting lentiviral vectors used in CAR-T and other engineered cell therapy programs.
Yes. Our experience includes two commercially approved lentiviral vector products and more than 500 commercial and PPQ manufacturing batches.
Lentiviral vector manufacturing is the process of producing viral vectors used that deliver genetic material into target cells for cell and gene therapy applications. Lentiviral vectors are commonly used in CAR-T therapies and other ex vivo and in vivo gene therapy programs. Thermo Fisher provides integrated lentiviral vector services from process development through GMP clinical and commercial manufacturing.
Thermo Fisher’s white-glove plasmid management service simplifies transient transfection programs by coordinating plasmid sourcing, supplier management, scheduling, and quality oversight. This integrated approach helps reduce complexity and supports more efficient manufacturing timelines.
Yes. Our teams have experience supporting both ex vivo and in vivo gene therapy programs, including CAR-T therapies, engineered cell therapies, and next-generation gene therapy platforms. We also have experience working with multiple lentiviral pseudotypes to support a variety of therapeutic applications.
Why choose Thermo Fisher for lentiviral vector manufacturing?
Thermo Fisher combines proven manufacturing experience, flexible production platforms, and integrated development services to support lentiviral vector programs from process development through commercial manufacturing. With expertise across transient transfection, upstream and downstream processing, analytical development, GMP manufacturing, sterile fill-finish, and white-glove plasmid management, we help customers accelerate development while reducing technical and manufacturing risk.
Helpful resources
Blog post
Advancing viral vector development through Quality by Design approach
Explore more on NysnoBio's partnership with Thermo Fisher, focusing on a quality by design approach to viral vector development and manufacturing.
Blog post
Rethinking 'Platforms’ in Cell and Gene Therapy Development
Discover why developers are looking beyond predefined platform processes and toward flexible customization, like our Rapid Development Framework.
Webinar
Discover the road to success for viral vector production
This webinar explores the critical elements of viral vector production for gene therapies, focusing on the technical and regulatory challenges inherent in this field.
Webinar
Assessing the application of standardized processes in cell and gene therapy development and manufacturing
This webinar features experts in cell and gene therapy (CGT) development, regulatory affairs, and CMC strategy, offering guidance on assessing the risks and rewards of standardized processes.