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.



RESEARCH GRADE (IPSWICH, MA, USA)
GMP GRADE (ROWLEY, MA, USA)
MANUFACTURING PROCESSES
  • Animal-derived material may be used during manufacturing or in final formulation (e.g., BSA)
  • Can remove animal-derived material, if needed
  • Manufacturing process may evolve as requirements to scale change; products subject to contractual change control provisions
  • Manufacturing Process and final formulation is animal-free
  • Fully characterized cell banks, dedicated chromatography resins, filtration into sterile containers
  • Strict change control system reduces risk and ensures additional transparency
PRODUCT ATTRIBUTES
  • Traceability information available for raw materials and finished product, upon request
  • Extensive specifications applied to all products, including custom specifications, upon request
  • Stringent assays performed on all products, with pass/fail criteria provided
  • TSE/BSE statements for all products, animal-free raw materials, processes and formulation
  • Compendial assays applied to all products, including bioburden and endotoxin levels
  • Qualified assays for all products, including E.coli gDNA and other contamination assays (quantitative result)
QA & REGULATORY
  • ISO 9001 and ISO 13485 certification
  • Robust manufacturing records across all products
  • Change management and lot disposition processes in place
  • ISO 9001 and ISO 13485 certification
  • Batch history files/batch records and defined CQAs and CPPs
  • Enhanced change management and lot disposition processes in place


 

"GMP-grade" is a branding term NEB uses to describe reagents manufactured 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 [email protected]. 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.
 

COMING SOON: Hi-T7 RNA Polymerase

RNA Polymerase designed for in vitro transcription of RNA at higher temperatures.
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.

Videos

  1. QualitySpecifications

    OEM & Customized Solutions Case Study: Quality & Specifications

    Learn how NEB helped a startup company manufacturing a novel therapeutic with GMP-grade enzyme.

To inquire about GMP-grade reagents

Contact us