Thermo Fisher, EF022SKB006, TheraPure™ GMP Pyrophosphatase, inorganic, 0.1 U/μL, 0.5 kU

Quantity: 0.5 kU
Unit Size: Each
Thermo Scientific TheraPure GMP* Pyrophosphatase, inorganic, is manufactured to ICH Q7 GMP principles and supported by a comprehensive documentation package. It is specifically designed for the development and manufacturing of mRNA therapeutics and vaccines. Also known as inorganic diphoshatase or PPase, it catalyzes the hydrolysis of inorganic pyrophosphate (PPi) generated by in vitro transcription reactions into two orthophosphates (Pi): P_2O_7^4- (PPi) + H_2O → 2 HPO_4^2- (2 Pi) Designed for process development and manufacturing TheraPure GMP Pyrophosphatase, Inorganic, 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—help 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 Pyrophosphatase 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 enzyme catalyzes the hydrolysis of 1 μmol of inorganic pyrophosphate in 1 min at 25°C. *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.