GMPBAnner

GMP-grade Product Manufacturing

For 50 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, in 2018 NEB opened a state-of-the-art 43,000 sq. ft. production facility in Rowley, MA for the manufacture of GMP-grade* products – approximately 15 minutes from our main campus in Ipswich, MA. 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 products include:

  • Bioburden and/or endotoxin specifications on products
  • Certified animal-free origin and manufacturing process
  • Qualified equipment, utilities, QC test methods and controlled manufacturing processes to deliver the highest levels of lot-to-lot consistency
  • Validated QC methods designed to provide customers with quantitative values, where appropriate

NEB’s GMP-grade products 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 products?

We are happy to work with you to assess your needs to help identify which solution will work best for you. Our research-grade products are highly pure and undergo stringent quality controls, and in many cases, will satisfy your needs. Our GMP-grade products are NEB’s highest quality grade product and are available for your further processing. The table below highlights our capabilities for both research-grade and GMP-grade products.

    RESEARCH-GRADE GMP-GRADE
mRNA PRODUCTION
Icon of mRNA synthesis with tube, representing GMP mRNA production 		 Ability to produce gram to kilogram quantities of mRNA    check 
Support production of commercially approved mRNA product(s)    check
Comparability reports supporting migration from research-grade to GMP-grade products for clinical production    check
PRODUCT
CUSTOMIZATION
Icon of large bottles with butterfly, representing NEB® Customized Solutions products or bulk products 		 Examples include but are not limited to:
High-concentration enzymes, formulation, fixed protein concentrations, packaging and fill size 

check

Contact our Customized
Solutions Team to discuss 

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Contact our Customized
Solutions Team to discuss
INFRASTRUCTURE 
Icon of building and two people, representing GMP infrastructure		 Animal-free facility       check
Risk-based Validation Programs check  check
Expanded qualification/validation requirements for facilities/utilities/environment/cleaning/process equipment/computer systems   check 
ISO 8 Clean Rooms ISO 5 Filling Hoods   check
Multiple production sites for business continuity   check  check
MANUFACTURING
PROCESSES
Icon of factory and cogs, representing GMP manufacturing 		 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
Icon of clipboard and tube, representing GMP product attributes

 Comprehensive panel of product contamination assays performed and Terminal filtration of final product check
 check
Validated assays with quantitative results
   check
Compendial assays applied to all products, including bioburden and endotoxin levels, where applicable.   check
TSE/BSE statements
  check
Animal-free raw materials, processes and formulation
 Contact our Customized
Solutions Team to discuss
 check

QA & REGULATORY Icon of quality certificate and ribbon

 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 elemental impurities, nitrosamine and residual solvents   check
Validated shipping configurations   check  check 
Temperature tracking devices for all GMP Grade shipments    check

SUPPORTED APPLICATIONS

   Research use or preclinical applications For further processing in clinical or commercial cGMP applications

 

What products does NEB offer in GMP-grade format?

Workflow

Product Name

Product Description

Notes

Amplification

phi29 DNA Polymerase

Replicative polymerase from the Bacillus subtillis phage phi29 and has exceptional strand displacement and processive synthesis properties with inherent 3´-5´ proofreading exonuclease activity

 The GMP-grade reagent has a different formulation than the commercially-available product. Learn more by contacting our Customized Solutions team.
Deoxynucleotide (dNTP) Solution Mix
 An equimolar (25mM) solution of ultrapure dATP, dGTP, dCTP, and dTTP
Q5® Hot Start High-Fidelity DNA Polymerase Q5 is composed of a novel polymerase that is fused to the processivity-enhancing Sso7d binding domain, improving speed, fidelity and reliability of performance. The formulation of the GMP-grade product is different than the catalog product.
 The GMP-grade reagent has a different formulation than the commercially-available product. Learn more by contacting our Customized Solutions team.

mRNA Synthesis

T7 RNA Polymerase

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

Inorganic Pyrophosphatase (E. coli)

Catalyzes the hydrolysis of inorganic pyrophosphate to form orthophosphate

RNase inhibitor (Murine)

Specifically inhibits RNases A,B and C

DNAse I (RNase-free)

NA specific endonuclease used for removal of contaminating genomic DNA from RNA samples and degradation of DNA templates in transcription reactions
DNase I Reaction Buffer 10X reaction buffer for use with DNase I (RNase-free)

Vaccinia Capping Enzyme

Adds the m7G-cap (Cap-0) to the 5´ end of the triphosphorylated and dephosphorylated RNA

Faustovirus Capping Enzyme

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

S-Adenosylmethionine (SAM)

Commonly used as a cofactor in enzymatic methylation reactions of nucleic acids, protein, lipids and secondary metabolites

HiScribe™ T7 RNA Polymerase Mix

Separate components available in GMP-grade format
NTPs  Individual NTPs available in GMP-grade format   
N1-Methyl-Pseudouridine-5-Triphosphate  Modified NTP available in GMP-grade format    

Nucleic Acid Therapeutic Manufacturing

BspQI

Type IIS restriction enzyme and Isoschizomer of LguI and SapI used to linearize plasmid DNA for mRNA therapeutics
XbaI Restriction enzyme used to linearize plasmid DNA for mRNA therapeutics
  
NEBExpress® Salt Active Nuclease, GMP Grade Engineered nuclease that leverages high salt conditions to remove nucleic acids in protein, adeno-associated virus (AAV) manufacturing, and other biopharma workflows
This product is available for purchase through the NEB catalog (NEB# G8024).

T4 DNA Ligase

Catalyzes the formation of a phosphodiester bond between juxtaposed 5´ phosphate and 3' hydroxyl termini in duplex DNA or RNA. Joins blunt end and cohesive end termini as well as repair single stranded nicks in duplex DNA and some DNA/RNA hybrids
T4 DNA Ligase Reaction Buffer At a 1X concentration this reaction buffer assures optimal activity of the T4 DNA Ligase enzyme

T5 Exonuclease

Double-stranded DNA specific exonuclease and single-stranded DNA endonuclease, initiates at the 5’ termini of linear or nicked double-stranded DNA

TelN Protelomerase

Cuts dsDNA at a TelN recognition sequence and leaves covalently closed ends at the site of cleavage

Didn’t see the product you are looking for? Reach out to our team for more information.

 

 


* “GMP Grade” and “GMP-grade” are branding terms NEB uses to describe products manufactured or finished at NEB’s Rowley facility. The Rowley facility was designed to manufacture products under more rigorous infrastructure and process controls to achieve more stringent product specifications and customer requirements. Products 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.

Products and content are covered by one or more patents, trademarks and/or copyrights owned or controlled by New England Biolabs, Inc (NEB). The use of trademark symbols does not necessarily indicate that the name is trademarked in the country where it is being read; it indicates where the content was originally developed. All other trademarks are the property of their respective owners. The use of this product may require the buyer to obtain additional third-party intellectual property rights for certain applications. For more information, please email busdev@neb.com.

Product portfolio

NEB manufactures and inventories a variety of enzymes at GMP-grade, meeting customer needs with short lead times. Learn more about our GMP-grade products.

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GMP-grade products for Nucleic Acid Therapeutic Manufacturing – Our highest quality products for manufacturing and testing nucleic acid therapeutics

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GMP-grade IVT products – Our highest quality products for the synthesis of  RNA from template to transcript

To inquire about GMP-grade reagents

Contact us