Viral vector development and manufacturing services

Unparalleled experience of manufacturing viral vector products for more than 20 years

Viral vector production employ 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

2 commercially approved products

and several others pending

700+ lots manufactured

700+ viral vector GMP clinical and commercial/PPQ lots manufactured in NA and Europe

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.

Viral vector types and platforms

Our suspension and adherent processes can be tailored to fit your product, indication, and delivery route based on our expertise in developing cGMP viral vector processes. We have a depth of experience in process development, optimization, scale up, technology transfer and GMP manufacturing at various scales. We have successfully executed over 700 cGMP batches in advanced therapies such as gene therapy, cell therapy, vaccine, oncolytic virus, non-viral vector, and immunotherapy.

Vector production platforms and processes

ADENOVIRAL   ADENO-ASSOCIATED VIRUS (AAV)        
Adherent + Suspension   Producer cell line + Adv   Adherent + Suspension   Adherent + Suspension
Mammalian cells infection   Mammalian cells infection   Mammalian cells transient transfection   Insect cells – infection

 

LENTVIRAL (LV)   RETROVIRAL (RV)   HERPESVIRAL (HSV)
Adherent + Suspension   Adherent + Suspension   Adherent + Suspension  
Mammalian cells transient transfection   Mammalian cells transient transfection   Mammalian cells infection  

 

MODIFIED VACCINIA ANKARA (MVA)   VESICULAR STOMATITIS VIRUS (VSV)
Suspension   Adherent  
Infection + avian cell line   Infection + Mammalian cells transient  

 

VIRUS-LIKE PARTICLES (VLP)  
Suspension
Insect cell + Mammalian Infection

Our team is experienced in supporting a variety of other viral platforms. For questions about our additional capabilities and capacity please contact us.

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 – suspension and adherent modalities, mammalian and insect cell culture, design of experiments, scale up
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  • Downstream processing – chromatography-based purification, optimization for increased yield/recovery, full capsid separation, specific purity requirements
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  • Assay development and analytics assay establishment, customization and development, platform assays, process development testing support, 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.

 

Process characterization

 

 

MS&T and process validation

 

 

Manufacturing

 

Quality control (QC)

 

Fill and finish

 

Scale-down model qualification Manufacturing support studies Suspension and adherent modalities Compendial assay verification, assay qualification, and validation Formulation evaluation
Design of experiments (DoE) Process validation plan and strategy Clinical and commercial-scale capacity Drug substance and drug product in-process and batch release testing Semiautomated and automated fill lines (Bausch + Strobel, Optima)
Critical material expiration/lot variation studies Failure mode and effects analysis (FMEA) Broad range of technologies and equipment cGMP stability studies Prequalified vial configurations
Mixing studies Validation support studies Cell and viral banking Reference Standard qualification Primary vial labeling and packaging
Critical quality attribute (CQA) analysis Technical transfer Process performance qualification (PPQ) Assay bridging and product comparability studies Up to 10,000 vial fill capacity per lot
Risk assessment   Engineering runs for tech transfer and/or scale up    
Critical process parameters (CPPs), Key process parameters (KPPs)   Up to 2,000L manufacturing batches    
Control strategy        

 

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 services diagram

 

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.


  • Initial facility fit

  • Detailed gap and risk assessment

  • Detailed process description

  • Raw materials

  • Sample plan

  • Tech transfer workshops

  • Engineering batches

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.


  • CMC dossier writing

  • Gap analysis and CMC dossier review

  • CMC regulatory strategic consulting

  • Health authority meeting, filing, and inspection support

  • Familiarity with shifting regulatory guidelines

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

De-risk your therapy development and advance to the clinic more quickly

Patheon Quick to Clinic™ viral vector services

You’ve worked through your options and weighed the advantages and challenges of different expression systems. If you want to get your therapy to market faster and reduce complexities along the way, Patheon’s Quick to Clinic™ viral vector services is a high-performance, scalable, end-to-end flexible manufacturing program for adeno-associated viral (AAV) and lentiviral (LV) vectors. This program enables you to deliver your gene therapy to the clinic by de-risking timelines and global regulatory filings without surprising out-of-pocket costs.

Learn more

Start conducting your toxicology studies in as little as six months

Direct-to-toxicology viral vector services

Toxicology studies are crucial for supporting pre-IND regulatory requirements and evaluating the risk-benefit ratio of drug candidates. However, acquiring high-quality toxicology materials can often stretch timelines, and the incompatibility between toxicology materials generation processes and current good manufacturing practice regulations can impede smooth transitions. Our direct-to-toxicology viral vector services program expedites the route to toxicology materials through our adeno-associated virus (AAV) and lentivirus (LV) production processes, completing them in as little as six months.

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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

Blog

Blog

Viral vector commercialization – Part 1: 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.

Read Blog
Blog

Blog

Viral vector commercialization – Part 2: Best practices in process validation lifecycle

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.

Read Blog
Article

Article

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.

View Article
Webinar

Webinar

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.

View Webinar
Infographic

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.

 

View Infographic
eBook

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 Article