Thermo Scientific™

TheraPure™ GMP DNase I, RNase-free (50 U/μL)

Thermo Scientific TheraPure GMP* DNase I, RNase-free, is manufactured to ICH Q7 GMP principles and supported by a comprehensive documentation자세히 알아보기

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.

For additional TheraPure GMP products or customization, please visit www.thermofisher.com/therapure.

*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.

사양

농도50 U/μL

색상Transparent

순도≥95%

pH7.1 to 7.9

용도(애플리케이션)In Vitro Transcription, DNA Template Removal

발현 시스템Pichia pastoris

질량29 kDa

효소DNase

함께 사용가능한 버퍼50 mM Tris-HCl, pH 7.5, 10 mM CaCl2, 50% glycerol

열 불활성화에 대한 민감성Yes

소스Bovine gene

수량50 kU

제품 유형DNase

연구 카테고리Drug Development

제품라인TheraPure™ GMP

생물학적 활성Dnase

형태Liquid

Unit SizeEach