Search Thermo Fisher Scientific
Raw materials for mRNA production |
From process development to clinical studies and manufacturing, our products and services for mRNA raw materials are designed to help meet critical process, scale, quality, and regulatory needs. You can accelerate the development and manufacturing of your mRNA vaccines and therapeutics with our TheraPure GMP* products and TheraPure custom services.
Partner with us to access:
- Technical partnership—Leverage tools and technical expertise to enable process development, scale-up, and commercial manufacturing
- Quality at scale—Seamlessly progress from preclinical development to commercial manufacturing and regulatory filing with the TheraPure GMP product portfolio or TheraPure custom services
- Proven products and services—Access standard on-shelf products, or world-class manufacturing facilities with top-notch quality systems and processes for raw materials, that have been used in clinical and commercial mRNA vaccines and therapeutics
Figure 1: Overview of mRNA production and applications. Quality and purity are critical to process performance and patient outcomes from Phase I to commercialization.
mRNA production materials
Figure 2: Overview of materials used in mRNA synthesis process for mRNA production.
TheraPure GMP product portfolio for scalable and seamless mRNA production
mRNA production for process development and cGMP commercial manufacture of an mRNA therapeutic or vaccine require careful choices in many key raw materials. Critical raw material considerations include:
Quality
Scalability
Proven products
Flexibility
Consistency
Documentation support
The TheraPure GMP product portfolio enables seamless scale-up of mRNA production—from pre-clinical and toxicology studies to process development and optimization through to clinical and commercial manufacturing.
TheraPure GMP product portfolio is supported by comprehensive quality system and documentation, including:
Standard concentrations and pack sizes are available to support you from process development to commercialization. Their smallest available pack sizes are shown below. Click on the product descriptions to view additional sizes.
(Top)
mRNA synthesis by in vitro transcription, using TheraPure GMP products
TheraPure GMP products are used in mRNA production on a global scale for vaccine and therapeutic development. The process includes DNA linearization, in vitro transcription, mRNA capping and tailing, purification, and analysis.
TheraPure custom services for mRNA raw materials
In addition to our standard TheraPure GMP product portfolio for mRNA production, custom materials and formulations are available through TheraPure custom services. Using our world-class product development, manufacturing, and quality systems, we offer three levels of services:
| TheraPure customization | TheraPure development | Therapure specialty manufacturing |
Customize existing TheraPure GMP product configurations such as:
| Develop a new raw material or modify an existing Therm Fisher product, such as:
| Manufacture your mRNA raw material according to your specifications, with access to:
|
TheraPure services—access to customized materials for producing nucleic acid therapeutics
Interested in our custom services?
(Top)
Manufacturing sites for raw materials for mRNA production
Our portfolios of mRNA raw materials are supported by industry-leading manufacturing capacity and capabilities, enabling a secure and reliable supply of materials. Our manufacturing sites are located across geographical locations with established supply chains that have the resilience to cope with unforeseen disruptions.
Vilnius (EU)
Milwaukee, WI (USA)
Carlsbad, CA (USA)
Austin, TX (USA)
A video tour of the Therapure GMP product manufacturing site in Vilnius, Lithuania
TheraPure GMP portfolio of nucleotides and enzymes are manufactured with rigorous quality standards for mRNA therapeutics and vaccine manufacturing. Take a quick video tour of the site where TheraPure GMP products are produced.
Resources
Brochures and flyers
Infographics
White papers
Posters
Webinars
eBooks
* “TheraPure GMP” refers to the quality level of the raw, ancillary, or starting materials to be used for further manufacturing. TheraPure GMP products are manufactured in facilities with ISO 9001–certified quality management systems that operate in accordance with relevant good manufacturing practice (GMP) principles, as outlined in ICH Q7 or equivalent guidance documents or standards.
For Research Use or Further Manufacturing. Not for diagnostic use or direct administration into humans or animals.
© 2023 Thermo Fisher Scientific Inc. All rights reserved. All trademarks are the property of Thermo Fisher Scientific and its subsidiaries unless otherwise specified.