TheraPure™ GMP Nucleotides (Thermo Scientific™)

Key Features

Thermo Scientific TheraPure GMP nucleoside triphosphates (NTPs) are manufactured to ICH Q7 GMP principles and supported by a comprehensive documentation package. They are suitable as core building blocks for mRNA synthesis in the development and manufacturing of mRNA therapeutics. Nucleotides ATP, CTP, GTP, and UTP are available and are supplied in sodium- or Tris-titrated solutions.

Designed for process development and manufacturing
TheraPure GMP nucleotides help accelerate mRNA vaccine and therapeutics production from preclinical development to commercialization by providing:
• Quality—meet critical product quality needs to accelerate therapeutic development and manufacture
• Minimal risk—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

Supported by unique quality system
TheraPure GMP nucleotides are supported by a comprehensive 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)

Two available formats
These two formats are offered to accommodate different mRNA manufacturing processes:
• 100 mM aqueous solution with Na+ titrated to pH 7.3–7.5 with NaOH
• 200 mM aqueous solution with Tris counterion titrated to pH 7.3–7.7 with Tris base

Modified nucleotides
TheraPure GMP N1-methylpseudo-UTP is also available.

*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.

Order Codes

Code	Description
R047SKB001	Catalog Number: R047SKB001 Unit Size: 3.5 mL Description: UTP Sodium Solution, 3.5 mL Concentration: 100 mM
R00014SKB002	Catalog Number: R00014SKB002 Unit Size: 5 mL Description: ATP Tris Solution, 5 mL Concentration: 200 mM
R00014SKB005	Catalog Number: R00014SKB005 Unit Size: 50 mL Description: ATP Tris Solution, 50 mL Concentration: 200 mM
R00014SKB004	Catalog Number: R00014SKB004 Unit Size: 500 mL Description: ATP Tris Solution, 500 mL Concentration: 200 mM
R044SKB001	Catalog Number: R044SKB001 Unit Size: 3.5 mL Description: ATP Sodium Solution, 3.5 mL Concentration: 100 mM
R044SKB002	Catalog Number: R044SKB002 Unit Size: 17 mL Description: ATP Sodium Solution, 17 mL Concentration: 100 mM
R0441SKB003	Catalog Number: R0441SKB003 Unit Size: 50 mL Description: ATP Sodium Solution, 50 mL Concentration: 100 mM
R0441SKB009	Catalog Number: R0441SKB009 Unit Size: 500 mL Description: ATP Sodium Solution, 500 mL Concentration: 100 mM
R00015SKB002	Catalog Number: R00015SKB002 Unit Size: 5 mL Description: CTP Tris Solution, 5 mL Concentration: 200 mM
R00015SKB005	Catalog Number: R00015SKB005 Unit Size: 50 mL Description: CTP Tris Solution, 50 mL Concentration: 200 mM
R00015SKB004	Catalog Number: R00015SKB004 Unit Size: 500 mL Description: CTP Tris Solution, 500 mL Concentration: 200 mM
R045SKB001	Catalog Number: R045SKB001 Unit Size: 3.5 mL Description: CTP Sodium Solution, 3.5 mL Concentration: 100 mM
R045SKB002	Catalog Number: R045SKB002 Unit Size: 17 mL Description: CTP Sodium Solution, 17 mL Concentration: 100 mM
R0451SKB003	Catalog Number: R0451SKB003 Unit Size: 50 mL Description: CTP Sodium Solution, 50 mL Concentration: 100 mM
R0451SKB009	Catalog Number: R0451SKB009 Unit Size: 500 mL Description: CTP Sodium Solution, 500 mL Concentration: 100 mM
R00016SKB002	Catalog Number: R00016SKB002 Unit Size: 5 mL Description: GTP Tris Solution, 5 mL Concentration: 200 mM
R00016SKB005	Catalog Number: R00016SKB005 Unit Size: 50 mL Description: GTP Tris Solution, 50 mL Concentration: 200 mM
R00016SKB004	Catalog Number: R00016SKB004 Unit Size: 500 mL Description: GTP Tris Solution, 500 mL Concentration: 200 mM
R046SKB001	Catalog Number: R046SKB001 Unit Size: 3.5 mL Description: GTP Sodium Solution, 3.5 mL Concentration: 100 mM
R046SKB002	Catalog Number: R046SKB002 Unit Size: 20.5 mL Description: GTP Sodium Solution, 20.5 mL Concentration: 100 mM
R0461SKB003	Catalog Number: R0461SKB003 Unit Size: 50 mL Description: GTP Sodium Solution, 50 mL Concentration: 100 mM
R0461SKB009	Catalog Number: R0461SKB009 Unit Size: 500 mL Description: GTP Sodium Solution, 500 mL Concentration: 100 mM
R00017SKB002	Catalog Number: R00017SKB002 Unit Size: 5 mL Description: UTP Tris Solution, 5 mL Concentration: 200 mM
R00017SKB005	Catalog Number: R00017SKB005 Unit Size: 50 mL Description: UTP Tris Solution, 50 mL Concentration: 200 mM
R00017SKB004	Catalog Number: R00017SKB004 Unit Size: 500 mL Description: UTP Tris Solution, 500 mL Concentration: 200 mM
R0471SKB006	Catalog Number: R0471SKB006 Unit Size: 20 mL Description: UTP Sodium Solution, 20 mL Concentration: 100 mM
R0471SKB002	Catalog Number: R0471SKB002 Unit Size: 100 mL Description: UTP Sodium Solution, 100 mL Concentration: 100 mM
R0471SKB003	Catalog Number: R0471SKB003 Unit Size: 500 mL Description: UTP Sodium Solution, 500 mL Concentration: 100 mM