[NEB] mRNA Manufacturing Solutions

NEB GMP 등급 시약 배너

NEB 에서 제공하는 GMP-grade RNA reagent를 소개합니다. 

    • Vaccinia Capping Enzyme – A full system for enzymatic capping based on the Vaccinia virus Capping Enzyme (VCE)

    • T7 RNA Polymerase – RNA Polymerase used for in vitro mRNA synthesis, and is highly specific for the T7 phage promoter

    • mRNA Cap 2′-O-Methyltransferase – mRNA Cap 2´-O-Methyltransferase adds a methyl group at the 2′-O position of the first nucleotide adjacent to the cap structure at the 5´ end of the RNA

    • RNase Inhibitor, Murine – RNase Inhibitor, Murine, specifically inhibits RNases A, B and C

    • Pyrophosphatase, Inorganic (E. coli) – Inorganic pyrophosphatase (PPase) catalyzes the hydrolysis of inorganic pyrophosphate to form orthophosphate

    • DNase I (RNase-free) – DNA-specific endonuclease used for removal of contaminating genomic DNA from RNA samples and degradation of DNA templates in transcription reaction
    • BspQI (now available) –  Type IIS restriction enzyme and Isoschizomer of LguI used to linearize plasmid DNA for mRNA therapeutics
NEB GMP-grade manufacturing 특징

Infrastructure & Approach

  • Purpose-built for GMP-grade manufacturing
  • Increased manufacturing output
  • ISO 8 clean rooms, ISO 5 filling hoods
  • Environmental monitoring of the facility
  • Animal-free facility

 

Manufacturing Processes

  • Lateral transfer from Ipswich to Rowley
  • Characterized master cell banks
  • Ampicillin-free processes
  • Dedicated chromatography resins
  • 0.22 micron-filtered final product

 

Product Attributes/Testing

  • TSE/BSE statements – animal-free raw materials, processes and formulation
  • Bioburden and endotoxin included for all products, with numerical values provided
  • Appearance, protein concentration, gDNA contamination and other current QCs qualified
  • Stability testing program
  • Contamination and other current QCs qualified

 

QA & Regulatory

  • ISO 9001 and ISO 13485 certification
  • Batch history files/batch records
  • Defined CQAs and CPPs
  • Enhanced change management and lot disposition processes
  • Customer support for regulatory submission
NEB mRNA 제조 솔루션 시스템
mRNA Synthesis Workflow & available GMP-grade reagents
NEB mRNA 제조 솔루션

*GMP-grade” is a branding term NEB uses to describe reagents manufactured at our Rowley, MA facility, where we utilize procedures and process controls to manufacture reagents under more rigorous conditions to achieve more stringent product specifications, and in compliance with ISO 9001 and ISO 13485 quality management system standards. NEB does not manufacture or sell products known as Active Pharmaceutical Ingredients (APIs), nor do we manufacture products in compliance with all of the Current Good Manufacturing Practice regulations.

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