Nucleic acid therapeutics hold great promise for treating a wide range of diseases—we invite you to partner with us to reach your nucleic acid therapeutics development goals. Explore our portfolio of high-quality raw materials designed for your oligonucleotide and mRNA synthesis to help you move your project from development to manufacturing and commercialization. Thermo Fisher Scientific provides expertise, services, and support to help you accelerate your productivity and innovation.
Platforms enabling nucleic acid therapeutic manufacturing across the globe
Our manufacturing facilities and platforms, located in geographic raw material centers of excellence, are deeply rooted in enzymology, nucleic acid chemistry, bioprocessing, and lipid chemistry.
|IVT RNA synthesis|
|IVT RNA synthesis|
Milwaukee, WI, USA
Oslo, Norway and Bedford, MA, USA
|Formulation and delivery|
Carlsbad, CA, USA
|ISO 9001 certified||ISO 9001, 13485 certified||ISO 9001 certified||ISO 9001, 13485 certified||ISO 9001 certified|
TheraPure quality for mRNA and oligonucleotides synthesis
TheraPure reagents from Thermo Fisher Scientific are designed for pharmaceutical manufacturers looking for core building blocks to use in research and manufacturing. These reagents are crafted in facilities with thoroughly documented quality systems and audited by accredited drug products manufacturing authorization holders. Strategically designed and carefully manufactured following the principles of 21 CFR 210/211, The Rules Governing Medicinal Products in the European Union, volume 4 GMP Part II and ICH Q7, TheraPure reagents help build the solutions to today’s challenges.
The reagent attributes that differentiate TheraPure from catalog products include:
Table 1. Comparison of TheraPure reagents to catalog products by application.
|TheraPure reagents||Catalog reagents|
|GMP grade||Research and clinical development grade||Research use only (RUO)|
|Technology||Host & Scale|
Table 2. TheraPure reagents portfolio for commercial applications.
|In vitro transcription enzymes||Nucleotides||Phosphoramidites|
Manufacturing scale-up to serve a global market
To better serve the growth in nucleic acid therapeutic development, we made significant investments in operational expansion with a new industrial scale manufacturing facility at our Bioscience Center of Excellence in Vilnius, Lithuania. And we’ll continue to invest so we can deliver leading innovation, support, and manufacturing capabilities to help accelerate your work.
- Purpose-built facility (5300 m2) for large-scale production of TheraPure reagents
- Manufacture and quality processes meet regulatory standards (following cGMP principles)
- Backed by more than 4 decades of enzymes and nucleotides manufacturing experience
Expertise and support at every step of the way
Our goal is to support you at every stage of the nucleic acid therapeutic development process. We offer integrated solutions across the workflow, custom capabilities, and the ability to scale with you as your project grows. Our skilled team from technical support staff to business development managers partner with your project team, providing the support you need to see your project to completion (including product customization, regulatory documentation, and more).
We recognize that as a critical raw material supplier, we play an important role in supporting your need for high-quality products, a stable supply chain, and robust risk mitigation strategies. Our network of manufacturing facilities enables us to supply high-quality products to our customers globally. Redundant manufacturing helps maintain that supply without interruption. Our sites are audit-ready, hosting hundreds of customer site audits per year.
Assistance with ordering, order status, and invoices
Technical assistance for all TheraPure product inquiries and selections, troubleshooting, and technical questions
Business development manager
Help navigate regulatory processes, custom products, and service offering from research to commercialization