GMPBAnner

GMP-grade Reagent Production

For over 45 years, NEB has been a world leader in the discovery and production of reagents for the life science industry. Decades of experience in practicing molecular biology has led to the design and manufacture of a broad product portfolio that has the potential to touch almost every stage of today’s biotechnology and therapeutic discovery and development process. Our commitment to product quality and stringent quality control practices means you can be confident our products will work for your application.

To better serve the needs of customers in regulated markets, NEB has opened a state-of-the-art 43,000 sq. ft. production facility in Rowley, MA for the manufacture of GMP-grade* materials – approximately 15 minutes from our main campus in Ipswich, MA, USA. This purpose-built facility includes Quality Control and Production functions ranging from a shipping/receiving area and dedicated warehouse, to separate inoculation preparation, fermentation, purification and fill suites.


Understanding your needs and minimizing risk

NEB's expertise in enzyme manufacturing positions us to best anticipate your needs and minimize the risk of transferring manufacture of your development materials to our GMP-grade production facility. The product attributes that differentiate NEB’s GMP-grade reagents include:

  • Bioburden and/or endotoxin specifications on reagents
  • Certified animal-free origin and manufacturing process
  • Qualified equipment, utilities, QC test methods and manufacturing processes to deliver the highest levels of lot-to-lot consistency

NEB’s GMP-grade reagents are produced in compliance with the ISO 13485:2016 Quality Management Standard, and are also in line with many of the principles defined in U.S. 21 CFR 820 “Quality System Regulation” – Medical Devices.


Not sure whether you need research-grade or GMP-grade materials?

We are happy to work with you to assess your needs to help identify which solution will work best for you. Our research-grade reagents are highly pure and undergo stringent quality controls, and in many cases, will satisfy your needs. The tables below highlights our capabilities for both research grade and GMP-grade materials.

    RUO
 GMP 
mRNA PRODUCTION
mRNA 		 Ability to produce gram to kilogram quantities of mRNA    check 
Support production of commercially approved mRNA product(s)    check
Comparability reports supporting migration from RUO to GMP-grade reagents for clinical production    check
PRODUCT
CUSTOMIZATION
Product Customization 		 Examples include but are not limited to:
High-concentration enzymes, formulation, packaging and fill size 

check

Contact our Customized
Solutions Team to discuss 

check

Contact our Customized
Solutions Team to discuss
INFRASTRUCTURE 
 Animal-free facility       check
Validation programs in place based on risk assessments check  check
Expanded validation requirements for facility/utilities/process equipment for GMP-grade   check 
ISO 8 Clean Rooms ISO 5 Filling Hoods   check
Multiple production sites for business continuity   check  check
MANUFACTURING
PROCESSES
 		 Ampicillin-free processes  Contact our Customized
Solutions Team to discuss
 check
Animal-free processes and final formulation Contact our Customized
Solutions Team to discuss
 check 
Characterized master cell banks
   check 

PRODUCT ATTRIBUTES/ TESTING

 Comprehensive panel of product contamination assays performed    check
 check
Qualified assays with quantitative results
   check
Compendial assays applied to all products, including bioburden and endotoxin levels    check
TSE/BSE statements – animal-free raw materials, processes and formulation
 Contact our Customized
Solutions Team to discuss
 check

QA & REGULATORY QA

 ISO 9001 and ISO 13485 certified check  check 
Batch history files/batch history records
 check   check
Consolidated batch history file/batch records and defined critical quality attributes and critical process parameters and QA reviews
   check 
Change management and lot disposition by Quality Unit   check
 check 
Regulatory support package including but not limited to the following risk statements – melamine, antibiotic, mutagenic and eelemental impurities, nitrosamine and residual solvent   check
Validated shipping configurations   check  check 

RECOMMENDED USE
Uses

   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.

Vaccinia Capping Enzyme

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

RNase Inhibitor, Murine

RNase Inhibitor, Murine, specifically inhibits RNases A, B and C.

T7 RNA Polymerase

RNA Polymerase used for in vitro mRNA synthesis, and is highly specific for the T7 phage promoter.
Pyrophosphatase, Inorganic (E. coli)

Inorganic pyrophosphatase (PPase) catalyzes the hydrolysis of inorganic pyrophosphate to form orthophosphate.
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.
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.
HiScribe T7 High Yield RNA Synthesis Components

Separate components available in GMP-grade format.
BspQI (now available)

Type IIS restriction enzyme and Isoschizomer of LguI used to linearize plasmid DNA for mRNA therapeutics.

Videos

To inquire about GMP-grade reagents

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