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
mRNA production, purification, lipid nanoparticle encapsulation, fill and release, and therapeutic applications.

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

mRNA production process showing key steps and in vitro transcription (IVT) reaction components

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 icon Quality   

Scalability icon Scalability  

Proven products icon Proven products    

  Flexibility icon Flexibility

Consistency icon Consistency

       Documentation support icon Documentation support

The TheraPure GMP product portfolio enables seamless scale-up of mRNA productionfrom 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:

  •    Manufacturing following relevant ICH Q7 GMP principles
  •    Animal origin–free (AOF) manufacturing process and raw materials
  •    Validated manufacturing processes and analytical methods
  • ✓   Product specific stability data
  •    Impurity profile
  • ✓   Verified compendial test methods, where applicable
  •    Manufactured in β-lactam–free facilities
  •    Quality support documents available including CoA, COO, TSE/BSE statement, nitrosamine statement, melamine statement, etc.
  •    Drug master file (DMF)

Quality documentation package for TheraPure GMP products

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.


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 customizationTheraPure developmentTherapure specialty manufacturing

Customize existing TheraPure GMP product configurations such as:

  • Product volume or pack size
  • Product packaging

Develop a new raw material or modify an existing Therm Fisher product, such as:

  • Concentration
  • Formulation
  • Buffer
  • Quality attributes
  • Specifications
  • New product development

Manufacture your mRNA raw material according to your specifications, with access to:

  • Comprehensive quality system and documentation
  • Global manufacturing capabilities
  • Global capacity and scale

 TheraPure services—access to customized materials for producing nucleic acid therapeutics

Interested in our custom services? 

Inquire now


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)

Vilnius (EU)

Milwaukee, WI (USA)

Milwaukee, WI (USA)

Carlsbad, CA (USA)

Carlsbad, CA (USA)

Austin, TX (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.

* “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.

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