NEB 에서 제공하는 GMP-grade RNA reagents를 소개합니다.
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
mRNA Synthesis Workflow & available GMP-grade reagents
*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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- 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
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- HiScribe T7 High Yield RNA Synthesis Components – Separate components available in GMP-grade format
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- BspQI (now available) – Type IIS restriction enzyme and Isoschizomer of LguI used to linearize plasmid DNA for mRNA therapeutics
- NEBuffer™ r3.1
NEB GMP-grade Reagents & RNA 관련 자료를 다운로드 받으세요!
Research-grade & GMP-grade Reagents 특징 비교 표
| RUO | GMP | ||
| mRNA Production | Ability to produce gram to kilogram quantities of mRNA | √ | |
| Support production of commercially approved mRNA product(s) | √ | ||
| Comparability reports supporting migration from RUO to GMP-grade reagents for clinical production | √ | ||
| Product Customization | Examples include but are not limited to: High-concentration enzymes, formulation, packaging and fill size |
√ Contact Customized |
√ Contact Customized |
| Infrastructure | Animal-free facility | √ | |
| Validation programs in place based on risk assessments | √ | √ | |
| Expanded validation requirements for facility/utilities/process equipment for GMP-grade | √ | ||
| ISO 8 Clean Rooms ISO 5 Filling Hoods | √ | ||
| Multiple production sites for business continuity | √ | √ | |
| Manufacturing Processes | Ampicillin-free processes | Contact Customized Solutions Team to discuss |
√ |
| Animal-free processes and final formulation | Contact Customized Solutions Team to discuss |
√ | |
| Characterized master cell banks | √ | ||
| Product Attributes/Testing | Comprehensive panel of product contamination assays performed | √ | √ |
| Qualified assays with quantitative results | √ | ||
| Compendial assays applied to all products, including bioburden and endotoxin levels | √ | ||
| TSE/BSE statements – animal-free raw materials, processes and formulation | Contact Customized Solutions Team to discuss |
√ | |
| QA & Regulatory | ISO 9001 and ISO 13485 certified | √ | √ |
| Batch history files/batch history records | √ | √ | |
| Consolidated batch history file/batch records and defined critical quality attributes and critical process parameters and QA reviews | √ | ||
| Change management and lot disposition by Quality Unit | √ | √ | |
| Regulatory support package including but not limited to the following risk statements – melamine, antibiotic, mutagenic and elemental impurities, nitrosamine and residual solvent | √ | ||
| Validated shipping configurations | √ | √ | |
| Recommend Use | Research use or preclinical applications | Clinical or commercial GMP applications |
