TheraPure™ GMP N1-Methylpseudo-UTP, 100 mM sodium solution

Thermo Scientific TheraPure GMP* N1-Methylpseudo-UTP is manufactured to ICH Q7 GMP principles and supported by a comprehensive documentation package. It is a modified uridine triphosphate (UTP) nucleotide designed specifically for the development and manufacturing of mRNA therapeutics and vaccines. TheraPure GMP N1-Methylpseudo-UTP is supplied as a 100 mM aqueous solution with a Na+ counterion titrated to pH 7.5–7.9 with NaOH.

Designed for process development and manufacturing

TheraPure GMP N1-Methylpseudo-UTP 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 a therapeutic by utilizing proven products
• Technical partnership—partner with 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 N1-Methylpseudo-UTP is supported by a 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)

N1-methylpseudo-UTP properties

According to literature, compared to UTP, this modified nucleotide has been reported to reduce immune responses and enhance translation while providing high protein yields (1).

Unmodified nucleotides

TheraPure GMP ATP, GTP, CTP, and UTP are available.

For additional TheraPure GMP products or customization, please visit www.thermofisher.com/therapure.

1. Andries O, Mc Cafferty S, De Smedt SC, Weiss R, Sanders NN, Kitada T. N(1)-methylpseudouridine-incorporated mRNA outperforms pseudouridine-incorporated mRNA by providing enhanced protein expression and reduced immunogenicity in mammalian cell lines and mice. J Control Release. 2015 Nov 10;217:337-44.

*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.

The use of the TheraPureTM GMP N1-Methylpseudo-UTP for certain applications may require a license under Third Party intellectual property rights and it is Customer’s sole responsibility to obtain any required license for such use. Thermo Fisher makes no representation or warranty that the use of TheraPureTM GMP N1-Methylpseudo-UTP is free from Third Party intellectual property rights, and will not indemnify the Customer against any Third Party infringement claim arising from Customer’s use of this product.