Producing mRNA for process development and cGMP commercial manufacturing of mRNA therapeutics or vaccines requires strategic decision-making regarding essential raw materials. Key considerations for critical raw materials include:
Streamline and expedite the production of your mRNA therapeutic or vaccine, guiding them seamlessly from preclinical development to commercialization with Thermo Scientific's TheraPure portfolio. This wide ranging product line encompasses restriction enzymes, in vitro transcription enzymes, nucleotides, modified nucleotides, and mRNA capping systems.
These fit-for-purpose, meticulously produced solutions cater to your quality and scalability needs while supporting your process requirements and regulatory standards.
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
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.
|Product attribute||Standard||TheraPure||TheraPure GMP|
|Large-scale (grams to kgs) production quantities available||No||Yes||Yes|
|Animal origin free (AOF) manufacturing processes and materials||Limited (as specified)||Yes||Yes|
|Animal origin– and β-lactam–free manufacturing equipment and facilities||No||No||Yes|
|Manufacture and documentation follows ICH Q& GMP guidelines||No||No||Yes|
|Validated product-specific manufacturing processes and analytical methods||No||No||Yes|
|Product specific stability||No||No (Product family only)||Yes|
|Animal origin and B-lactam free manufacturing equipment and facilities||No||No||Yes|
|Comprehensive regulatory support documentation||No||Limited (TSE/BSE, COO, COA only)||Yes|
|Recommended use||Research Use Only||Proof of concept, research, and pre-clinical development||Clinical and commercial manufacturing|
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.