
GMP-grade Reagent Production
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 |
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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 our Customized Solutions Team to discuss |
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Animal-free processes and final formulation | Contact our Customized Solutions Team to discuss |
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Characterized master cell banks |
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PRODUCT ATTRIBUTES/ TESTING |
Comprehensive panel of product contamination assays performed | ||
Qualified assays with quantitative results |
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Compendial assays applied to all products, including bioburden and endotoxin levels | |||
TSE/BSE statements – animal-free raw materials, processes and formulation |
Contact our Customized Solutions Team to discuss |
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QA & REGULATORY |
ISO 9001 and ISO 13485 certified | ||
Batch history files/batch history records |
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Consolidated batch history file/batch records and defined critical quality attributes and critical process parameters and QA reviews |
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Change management and lot disposition by Quality Unit | |||
Regulatory support package including but not limited to the following risk statements – melamine, antibiotic, mutagenic and eelemental impurities, nitrosamine and residual solvent | |||
Validated shipping configurations | |||
RECOMMENDED USE |
Research use or preclinical applications | Clinical or commercial GMP applications |
"GMP-grade" is a branding term NEB uses to describe reagents manufactured or finished at NEB’s Rowley facility. The Rowley facility was designed to manufacture reagents under more rigorous infrastructure and process controls to achieve more stringent product specifications and customer requirements. Reagents manufactured at NEB’s Rowley facility are manufactured in compliance with ISO 9001 and ISO 13485 quality management system standards. However, at this time, NEB does not manufacture or sell products known as Active Pharmaceutical Ingredients (APIs), nor does NEB manufacture its products in compliance with all of the Current Good Manufacturing Practice regulations.
This content is covered by patents, trademarks and/or copyrights owned or controlled by New England Biolabs, Inc. For more information, please email us at gbd@neb.com. The use of these products may require you to obtain additional third party intellectual property rights for certain applications.
Product portfolio
NEB manufactures and inventories the following enzyme specificities at GMP-grade, meeting customer needs with short lead times. Learn more about our GMP-grade IVT reagents.
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Vaccinia Capping Enzyme A full system for enzymatic capping based on the Vaccinia virus Capping Enzyme (VCE) |
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RNase Inhibitor, Murine
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RNA Polymerase used for in vitro mRNA synthesis, and is highly specific for the T7 phage promoter.
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Pyrophosphatase, Inorganic (E. coli) Inorganic pyrophosphatase (PPase) catalyzes the hydrolysis of inorganic pyrophosphate to form orthophosphate. |
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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. |
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DNase I (RNase-free) DNA-specific endonuclease used for removal of contaminating genomic DNA from RNA samples and degradation of DNA templates in transcription reactions. |
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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. |