Thermo Fisher, EN052SKB008, TheraPure™ GMP DNase I, RNase-free, 50 U/μL, 2500 kU

Quantity: 2500 kU
Unit Size: Each
Thermo Scientific TheraPure GMP* DNase I, RNase-free, is manufactured to ICH Q7 GMP principles and supported by a comprehensive documentation package. It is designed for DNA template removal during the development and manufacturing of mRNA therapeutics and vaccines. As an endonuclease it digests both single- and double-stranded DNA. Designed for process development and manufacturing TheraPure GMP DNase I, RNase-free 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 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 DNase I 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) Enzyme activity One unit of DNase I completely degrades 1 μg of plasmid DNA in 10 minutes at 37°C. One DNase I unit is equivalent to 0.3 Kunitz unit.*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.