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Plainville, Massachusetts, US
Viral vector, biologics, and sterile fill-finish manufacturing in one US location
Plainville at a glance: This campus integrates the following capabilities in a single US facility:
Supported by comprehensive risk assessments, robust quality systems, and facility controls designed to enable the safe manufacture of multiple modalities at one location, we deliver flexible manufacturing solutions that reduce technology transfers, help to accelerate timelines, and simplify supply chains.
Our decades of drug development experience spans every stage of the product lifecycle, with a proven track record of supporting innovators from early development through commercial manufacturing. This reflects our deep expertise in helping novel therapies progress from concept to clinic and beyond.
To learn more about this location, download the site capabilities fact sheet.
Key highlights of Thermo Fisher Scientific’s global network:
More than 70% of the customers we support are small and emerging biotech companies
Our network has manufactured more than 1,200 viral vector batches representing over 200 products
We have supported more than 985 biologics batches, including over 32% complex molecules
To date, we have manufactured 15 commercially approved viral vector and biologic products
Explore Thermo Fisher Scientific's integrated development and manufacturing capabilities for viral vectors, biologics, and sterile fill-finish at our Plainville, MA site.
Viral vector manufacturing
Manufacturing services supporting programs from early-phase development through scaled-up production.
| Process development Ambr® 15, 250 mL, 2 L, 50 L, 250 L, and 500 L scales for DoE through IND-enabling milestones |
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| Process characterization and validation Raw material evaluation, risk analysis, characterization studies, and assessment reports |
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| Analytical services Development and optimization to accurately assess product quality and safety attributes |
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| GMP manufacturing at scale Scalable GMP manufacturing with production capacity ranging from 50 L to 2,000 L |
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| Integrated sterile fill-finish On-site certified capacity for batch sizes of up to 15,000 vials, ranging from 0.5 mL to 10 mL, with flexibility for custom configurations |
Biologic manufacturing
Monoclonal antibody (mAb), bispecific, and enzyme biologic manufacturing with sterile fill-finish.
| Client gene design, cell line, and process |
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| Technology transfer We can complete process transfer, qualification, and optimization |
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| Drug substance manufacturing Scale-up and GMP manufacturing at the 500 L scale |
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| Integrated sterile fill-finish On-site certified capacity for batch sizes of up to 15,000 vials, ranging from 0.5 mL to 10 mL, with flexibility for custom configurations |
Sterile fill-finish
Comprehensive aseptic sterile fill-finish capabilities for clinical and commercial supply.
| Viral vector and biologic drug substance On-site GMP manufacturing |
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| Integrated sterile fill-finish Precision filling using automated filling equipment within a Grade A isolator to help ensure a sterile environment |
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| Clinical pack and label Comprehensive packaging and labeling services to support all stages of manufacturing |
One US facility that provides end-to-end development and manufacturing capabilities, with integrated regulatory support, quality control, and program management at every stage.
Why choose Thermo Fisher Scientific?
- Flexible process and equipment options, using either your existing platform or our proven technologies
- End-to-end, integrated development and manufacturing platforms for biologics, viral vectors, and mRNA therapies
- One location for GMP drug substance and drug product manufacturing, from scale-up through production
- Access to global regulatory expertise spanning process development through commercial manufacturing
- On-site analytical development and quality control support, including for select analytical methods
Whether you're developing your first therapy or expanding an established commercial portfolio, you can leverage Thermo Fisher Scientific's experience, scalability, and technical expertise to help accelerate your path to patients.
Frequently asked questions (FAQs):
Yes. Our Plainville, Massachusetts, site offers US-only drug substance and drug product manufacturing, providing an end-to-end solution for customers seeking domestic manufacturing. As your program evolves, you can also leverage our global network of manufacturing sites to support regional, clinical, and commercial supply needs. Learn more about our global manufacturing network.
Yes. Our Plainville, Massachusetts, site features dedicated manufacturing suites for IgG, bispecific, Fc-fusion, and viral vector drug substance manufacturing, as well as sterile fill-finish capabilities.
We manufacture adeno-associated virus (AAV), adenovirus (AdV), herpes simplex virus (HSV), lentivirus (LVV), retrovirus (RV), and other viral vectors for gene therapy and oncolytic applications.
Our sterile fill-finish capabilities include:
- PUPSIT-compliant filtration assemblies, prequalified bracketed filling configurations, and standardized bills of materials.
- Precision, Annex 1-compliant filling equipment utilizing isolator technology.
- Certified capacity to handle batch sizes of up to 15,000 vials, ranging from 0.5 mL to 10 mL, with flexibility for custom configurations.
- Comprehensive labeling and packaging services for all stages of production.
Helpful resources
Brochure
PDS Steriles Capabilities: US- & EU-based facilities
State-of-the-art steriles PDS services
Blog post
Viral vector commercialization – Part 3: Specialized regulatory support
Find detailed regulatory considerations when preparing viral vectors for commercialization and best practices to address them.
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.
Webinar
Benefits of an integrated approach to gene therapy development and manufacturing
Thermo Fisher Scientific's expert will take you through the development and commercialization of viral vectors for gene therapy, so you can navigate these hurdles and deliver the project in a timely, cost-effective manner. With integrated gene therapy development and manufacturing, you can benefit more than a customized solution. It improves coordination, streamlines decision-making, and uses resources more efficiently.