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ThermoFisher Scientific Patheon Pharma Services
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Viral vector development and manufacturing services

Unparalleled experience manufacturing viral vector products for more than 20 years

Viral vector production employs complex processes resulting in varying challenges throughout the product lifecycle. The main issues revolve around selecting a production system, optimizing product quality, and building standardization to enable a robust CMC approach.

Thermo Fisher Scientific viral vector services (VVS) is a leading CDMO that offers a full range of services for the development and commercialization of viral vectors and gene therapy-based vaccines. Our viral vector end-to-end capabilities include process and analytical development, clinical and commercial manufacturing, and fill-finish services. With an extensive network of production sites, global clinical supply chain capabilities, and in-depth viral vector technical and regulatory expertise, we can help you de-risk and expedite your therapy's path to market.

20+ years viral vector experience

Development and manufacturing

3 commercially approved products

and several others pending

900+ lots manufactured

900+ viral vector lots manufactured, including GMP clinical and commercial lots over time

50+ drug substance suites

and 12 drug product suites

The expertise and experience to design a path from early discovery to commercial manufacturing

In addition to core viral vector manufacturing services, we also provide upstream and downstream offerings to support every aspect of your drug development and manufacturing journey. From early translational services to help optimize your small-scale processes to cold chain logistics to facilitate the secure storage and distribution of your final product, we provide end-to-end solutions for managing unique gene therapy and gene-modified cell therapy projects.

Suspension up to 2,000L

Viral production (transient transfection, viral infection, and stable producer)

Multiple virus types (AAV, LV, AdV, RV, MVA, VSV, and more)

Adherent – flatstock & iCELLis technology

Viral vector services program offering

Early development through late-phase commercial

Bioanalytical, clinical trial

Regulatory support

Cold chain logistics, transportation, shipping, packaging

Viral vector types and platforms

While the viral vector market is dominated by adeno-associated viruses (AAV) and lentiviral vectors (LV), there is also a range of less commonly used vectors. Our suspension and adherent processes can be tailored to fit your product, indication, and delivery route based on our diverse expertise in viral vector production. Regardless of your vector strategy, you can be confident that we have the experience and resources to smoothly manage any project.

Viral vector CDMO capabilities from discovery to commercialization

From process development and process characterization to manufacturing, QC, and fill finish, VVS has the broad capabilities and expertise needed to develop and manufacture your viral vector product.

With over 20 years of experience creating viral vector products, we have established strategies for upstream and downstream process development and optimization, process scale up, and at scale pilot run standards. Throughout your product life cycle, you'll be guided through each milestone with checkpoints to ensure you meet all quality standards.

Upstream processing
Downstream processing
Assay development and analytics assay establishment

Suspension and adherent modalities

Chromatography-based purification

Customization and development

Mammalian and insect cell culture

Optimization for increased yield/recovery

Platform assays

Design of experiments

Full capsid separation

Process development testing support

Scale up

Specific purity requirements

Pre-clinical material testing
Viral vector process development services

 

Our dedicated viral vector facilities manufacture cGMP-compliant viral vectors for clinical and commercial applications around the world. The 50 drug substance suites can be used for various production modes and technologies (cell factories, iCELLis, SUBs, etc.). Using semi and fully automated fill lines and a range of prequalified vial and container closure systems, we offer a comprehensive aseptic fill and finish service. Through our global technology transfer strategy, we facilitate the successful transfer and establishment of processes into our facilities from our customers or from internal development and pilot laboratories. Quality control (QC) capabilities are available at each site for in-process, release, and stability testing using approved or validated methods.

Viral Vector Services Manufacturing Capabilities - Thermo Fisher Scientific

 

Testing and analytical development are crucial to establishing regulatory-compliant processes and products. Investing continuously in new technologies and in-house resources has allowed us to adapt to changing regulatory and customer needs. A consistent method of execution ensures streamlined batch release testing, accelerating your product's release.

 

Each viral vector site has analytical testing and quality control capabilities. At every stage of clinical development and commercial-scale manufacturing, our experts support your analytical needs by using next-generation analytical methods where applicable, and supporting development and testing with quality focused processes.

Viral vector analytical development

 

Learn how we can help you with tips and aspects to consider for robust viral vector analytical characterization: download infographic.

Technology transfer is often associated with risks that may affect costs and timelines. We have extensive experience in technology transfer including scaling, moving projects between facilities as well transferring external processes in our facilities. We can execute the transfer quickly and effectively to keep your project on track and preserve supply. Our approach is flexible, driven by your deadlines, and we are dedicated to getting the job done right the first time.

Process

Detailed process review

Resource planning

Gap assessment

Risk assessment

Manufacturing process
(start to finish)

BOM,
material flow

Analytical

Detailed analytical method/
testing review

Resource planning, outsourcing

Gap assessment

Risk assessment

Sampling/
testing plan

BOM

The regulatory landscape for advanced therapies is constantly evolving, and what is acceptable today may not be adequate tomorrow. Over 15 years, we have supported customers with global regulatory interactions (US, EU, and Canada), CMC regulations, guidelines, and inspections. In addition to providing document reviews and gap analyses, our regulatory services team can generate documents to reduce the number of intermediaries and filing lead times in preparing regulatory filings.

Regulatory dossier preparation
Regulatory expertise provision
Regulatory meetings support
Regulatory compliance support
  • Author and/or review CMC dossiers (complete or partial modules) for major jurisdictions in CTD format:
    • Early-and late-stage development
    • Marketing applications
    • Post-approval changes
  • Regulatory submissions strategy
  • Responses to health authority question
  • Strategic regulatory consulting
    • Regulatory review and gap assessments
    • Ad hoc advice across product life-cycle
  • Projects regulatory liaison
  • CMC-specific trainings and workshops
  • Assistance in regulatory agencies pre-submission / advice meetings:
    • Filing strategy outlines
    • Requests
    • Briefing books
    • Minutes
  • Site foreign registration packages
  • Site related reference documents
  • Product related documents (e.g. declarations)
  • Change controls evaluation
  • Document legalization

Learn how we can help you to navigate regulatory requirements for cell and gene therapies: download fact sheet.

The successful commercialization of your advanced therapy depends on rigorous technology transfer, robust process validation, and specialized regulatory support. Partnering with an organization capable of scaling alongside you ensures sustained capacity, while integrated services streamline your value chain, minimizing risk and accelerating market entry.


  • 8 upcoming and ongoing PPQs across VVS sites

  • 8 completed process characterizations

  • 350+ commercial DS batches

  • 250+ commercial DP Batches

  • 3 approvals with major regulatory agencies (FDA, EMA, Japan)

  • Manufactured in US and EU

Viral vector service offerings

To provide flexibility and agility for our customers, we offer several different pathways for viral vector development to support various manufacturing strategies, timelines, and customization needs.

Rapid Development Framework™ (open platform)

Accelerated development approach for AAV and LV leveraging pre-established processes and analytics with time to delivery of GMP drug product in as little as 9 months.

Customizable development

Flexible development and process solutions for a variety of viral vector types (AAV, LV, AdV, RV, HSV, MVA, VSV, and others) with time to delivery of GMP drug product in 12+ months.

Client tech transfer

Direct transfer and manufacturing of client process with time to delivery of GMP drug product in 9+ months.

Our viral vector manufacturing sites

A global footprint of over 555,000 square feet is available to develop and manufacture viral vector products. We can find suitable capacity, talent, and technology to ensure a robust product and efficient production processes at multiple sites. We are leveraging the viral vector knowledge and experience from Brammer Bio and Henogen S.A., as well as clinical trial capabilities from Fisher Clinical Services.

Helpful Resources

eBook
Cell Therapy Logistics Advanced Therapy
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.
Infographic
Regulatory pathways for CGT and ATMP products
CGT is one of the world's fastest-growing therapeutic areas today. Instead of treating patients for the rest of their lives, these therapies offer them hope of a cure. In this infographic, we will review three tips for achieving regulatory success.
Presentation
Preparing viral vector productions for commercialization
Gene therapy vectors are rapidly approaching the commercial space so commercial readiness is critical for success. Watch our webinar to learn about our capabilities and approaches for preparing viral vectors for commercialization.
Strategies to accelerate drug development through harmonization of early and late stage processes
This technical article presents a harmonized and streamlined approach established at Thermo Fisher Scientific for manufacturing AAV and LV vectors for discovery research using technologies and processes mirroring current GMP platforms.
Blog post
Regulatory Support for Viral Vector Commercialization
Learn more about the robust viral vector process validation cycle, which includes various assessments and studies to ensure the safety, efficacy, and quality of viral vectors.
Blog post
Tech transfer process for commercial viral vector manufacturing
Learn how tech transfers can help develop and manufacture viral vectors at scale, accelerate vaccine and gene therapy commercialization, and provide expertise.
Blog post
Best practices for viral vector process validation
Find detailed regulatory considerations when preparing viral vectors for commercialization and best practices to address them.