GMP-grade Products for Nucleic Acid Therapeutic Manufacturing

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For nearly 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. 

From research to nucleic acid therapeutic production, NEB’s GMP-grade product portfolio will meet your needs

NEB’s portfolio of research-grade (RUO) and GMP-grade* products enables bench to commercial-scale production batch sizes. When it is time to scale up and optimize reaction components, our standalone reagents are readily available in formats matching our GMP-grade offering, enabling a seamless transition to large-scale manufacturing.

Enabling large-scale nucleic acid therapeutic manufacturing

NEB manufactures and inventories the following enzymes at GMP-grade to support the production of commercially approved mRNA and DNA product(s) meeting customer needs with short lead times:

Workflow

Product Name

Product Description

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
Deoxynucleotide (dNTP) Solution Mix
 An equimolar (25mM) solution of ultrapure dATP, dGTP, dCTP, and dTTP 
Q5® Hot Start High- Fidelity Master Mix

COMING SOON
 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.
 

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

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

HiScribe™ T7 RNA Polymerase Mix

Separate components 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

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

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




 
* "GMP-grade" is a branding term 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. See www.neb.com/trademarks. The use of products may require the buyer to obtain additional third-party intellectual property rights for certain applications. For more information, please email busdev@neb.com.

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