Thermo Fisher, ER023SKB004, TheraPure™ GMP Eam1104I Restriction Enzyme, 20 U/μL, 100 kU

Quantity: 100 kU
Unit Size: Each
Thermo Scientific TheraPure GMP* Eam1104I Restriction Enzyme is manufactured to ICH Q7 GMP principles and supported by a comprehensive documentation package. It is a Type IIS restriction endonuclease (isoschizomers: Bst6I, EarI) designed for DNA template linearization.Designed for process development and manufacturing TheraPure GMP Eam1104I Restriction Enzyme 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 Eam1104I Restriction Enzyme 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) Full enzyme activity in recommended buffers TheraPure GMP Eam1104I Restriction Enzyme exhibits 100% activity in the recommended buffer and reaction conditions. To help ensure consistent performance, Thermo Scientific restriction enzyme reaction buffers contain premixed rBSA, which helps enhance the stability of enzyme. Enzyme activity One unit is defined as the amount of enzyme required to digest 1 μg of lambda DNA or plasmid in 1 hour at 37°C in 50 μL of assay buffer. *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.