Description
Product Type: GTP, sodium solution
Concentration: 100 mM
Quantity: 500 mL
Format: Business supply
Unit Size: Each
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 manufacturingTheraPure 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 scaleSupported by unique quality systemTheraPure 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 formatsThese 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 baseModified nucleotidesTheraPure 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.
