Choose your raw materials wisely
Pictured: Woman in lab coat, safety glasses, and gloves holding a tube and eye dropper / Courtesy of Thermo Fisher Scientific
The materials you choose to produce mRNA can mean the difference between success and setback. Selecting the materials that are manufactured using a fully validated process that consistently produces the same result, with minimal variability can help speed and ease your path in the development and manufacturing of mRNA vaccines and therapeutics.
Meeting a spec once isn’t good enough: verified or validated?
Using verified processes to make raw materials for producing mRNA doesn’t guarantee you get exactly the same product with every lot. However, materials made by validated processes can deliver very consistent products with the minimal lot‑to‑lot variability you need for producing mRNA therapeutics.
Figure 1. Analyses of materials manufactured by a verified vs. validated process / Courtesy of Thermo Fisher Scientific
Thermo Scientific™ TheraPure™ GMP* nucleotides and enzymes are manufactured and tested by validated processes and methods that follow relevant ICH Q7 GMP and ICH Q2 quality guidelines.
Is GMP grade good enough?
“GMP grade” is just a marketing term. It’s not a measurement of product quality. The quality attributes of products labeled as GMP grade can vary widely and put your project at risk. See the infographic what it means to go beyond GMP to help ensure more robust development and manufacturing process.
TheraPure GMP products for mRNA process development and manufacturing are manufactured to stringent quality requirements. Download the white papers to learn how using TheraPure GMP products can help reduce development risks and streamline process development and manufacture of mRNA therapeutics and vaccines.
Figure 2. TheraPure GMP quality management system / Courtesy of Thermo Fisher Scientific
Want to learn more?
Browse through our curated selection of learning resources to enable your success in development of mRNA therapeutics and vaccines. View available technical assets related to raw materials for mRNA production, process development using in vitro transcription, scale-up synthesis of mRNA, and more.
Connect with Thermo Fisher Scientific today for your mRNA raw materials at thermofisher.com/therapure
* “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.
