TheraPure™ GMP dNTPs

TheraPure GMP* dNTPs are suitable as core building blocks for IVT (in vitro transcription) template preparation by PCR or isothermal amplification technologies that can be used in the development and manufacturing of RNA or DNA therapeutics.

Designed for process development and manufacturing

TheraPure GMP dNTPs help accelerate RNA and DNA therapeutics production from preclinical development to commercialization by providing:

• Quality—critical product quality attributes to accelerate therapeutic development and manufacture
• Secure supply—a secure, stable, and consistent supply of product at a global scale
• Technical collaboration—solution-driven expert support across the production and development process

Comprehensive quality system

TheraPure GMP dNTPs are supported by an extensive quality system and documentation:

• Manufactured according to relevant ICH Q7 GMP guidelines
• Animal-origin-free (AOF) and beta-lactam-free manufacturing processes, materials, and facilities
• Validated manufacturing processes
• Extensive set of validated/verified compendial assays
• Validated analytical test methods following ICH Q2 guidelines whenever possible
• Individual product stability data
• Comprehensive impurity profiles
• Drug master files (DMF) 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.