TheraPure™ GMP S-Adenosyl-L-Methionine, 32 mM

Thermo Scientific TheraPure GMP S-Adenosyl-L-Methionine for post-transcriptional capping is manufactured to ICH Q7 GMP principles and supported by a comprehensive documentation package. It is designed for the synthesis of mRNA in the development of mRNA therapeutics and vaccines.

Post-transcriptional capping involves adding a 5' cap structure to mRNA after transcription, which improves mRNA stability and translation efficiency. TheraPure GMP S-Adenosyl-L-Methionine is a high-purity reagent used as a methyl group donor in post-transcriptional capping for Cap-0 and Cap-1 structures. Capping efficiency can reach >95%.

Designed for process development and manufacturing

TheraPure GMP S-Adenosyl-L-Methionine helps accelerate mRNA vaccine and therapeutics production from preclinical development to commercialization by providing:

• Quality—meet critical product quality needs to help accelerate therapeutic development and manufacturing
• Minimal risk—helps reduce risks in developing therapeutics by utilizing proven products
• Technical partnership—partner with an expert product and technical support
• Secure and consistent supply—count on a secure and stable supply of product at a global scale

Comprehensive quality system

TheraPure GMP S-Adenosyl-L-Methionine is supported by an extensive quality system and documentation, including:

• Manufactured to relevant ICH Q7 GMP guidelines
• Animal-origin-free (AOF) manufacturing processes, materials, and facilities
• Validated manufacturing processes and analytical test methods
• Comprehensive impurity profiles
• Verified compendial assays where applicable
• Product stability data
• Tested by analytical methods following ICH Q2 guidelines whenever possible
• Drug master file (DMF) support upon request

For additional TheraPure GMP products or customization, please visit www.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.