Materials for mRNA Therapeutics Production

Proven supplier to help minimize your risks in mRNA therapeutics and vaccine commercialization

Selecting the appropriate raw materials is the essential first-step to expediting the manufacturing process development of mRNA therapeutics and ensuring a smooth transition to commercialization. Thermo Scientific's TheraPure portfolio was created to accommodate your requirements. TheraPure products are designed to support your needs for early process development activities, creating a bridge to TheraPure GMP, which follows the most up-to-date guidelines in compliance to current Good Manufacturing Practice (cGMP), and is an exceptional choice for the late process development and commercialization stages with in-depth documentation.

This comprehensive product line includes restriction enzymes, in vitro transcription enzymes and proteins, nucleotides, modified nucleotides, mRNA capping, and mRNA tailing systems. Our extensive solutions and custom services are designed to meet your specific quality, purity requirements, and scalable batch-to-batch consistency.

In addition to offering a secure and dependable supply chain, we are committed to staying ahead of innovative solutions in every step of the mRNA manufacturing process. Isothermal amplification techniques for IVT DNA template amplification are cell-free processes that have been gaining attraction due to high efficiencies as alternatives to technologies such as PCR or plasmid DNA amplification. This trending technology uses polymerase with strand displacement activity to produce and amplify DNA at a constant temperature.

Rolling circle amplification (RCA) solution

Introducing the complete system to produce DNA templates for IVT that uses the RCA method of isothermal amplification. Different from traditional plasmid DNA template production, the RCA method encompasses a less complex, quicker-to-perform process that is cell-free. The new method reduces the risks of contamination and further enables the potential for new types of RNA therapeutics.

mRNA production involves template linearization, in vitro transcription, DNA removal, and post-transcriptional modification. Below is a summary of many of the materials typically used in mRNA production.

mRNA building blocks	In vitro transcription	mRNA modification
Nucleotides ATP, CTP, GTP, UTP Modified nucleotides N1-methylpseudo-UTP	Restriction enzymes T7 RNA polymerase Pyrophosphatase, inorganic RNase inhibitor DNase I Proteinase K	Capping systems Poly(A) polymerase 2’-O-methyltransfrase S-adenosyl methionine

Thermo Fisher Scientific offers two types of products for mRNA production: TheraPure and TheraPure GMP*. TheraPure grade materials are recommended for process optimization and early development (proof of concept, research, and preclinical studies). Upon transitioning to clinical and commercial cGMP manufacturing, TheraPure GMP material, which is manufactured with added process controls and includes documentation to support regulatory submissions, is recommended.

• TheraPure—Advancing Early Development and Process Optimization: TheraPure grade materials are an exceptional choice for your initial stages of process development. Whether you are focused on proof of concept, process research, or engaged in preclinical studies, TheraPure materials provide the flexibility and capabilities you need for process development and optimization.
• TheraPure GMP—Meeting Clinical and Commercial Demands: As your mRNA production progresses toward clinical trials and commercial cGMP manufacturing, TheraPure GMP materials step in. Manufactured with stringent process and quality controls and accompanied by comprehensive documentation to support regulatory submissions, TheraPure GMP is the recommended choice. To learn more, watch this quality tour video

The TheraPure portfolio of products can also be custom-formulated to meet your process development and manufacturing needs. Many of these products have been consistently manufactured at a global scale and have been successfully used in several mRNA therapeutics and vaccines. 

* “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.
 

Use of the products may vary. For specific use statements, please see product literature.