GMP-Grade Reagents for Genetic Medicines
A Scalable Genetic Medicine Manufacturing Strategy Starts with the Right Raw Materials
NEB GMP-grade* reagents help reduce technical, regulatory, and supply-chain risk with quality-controlled raw materials designed to support consistent manufacture of genetic medicines from development through commercial production.
For over 50 years, New England Biolabs has been a trusted partner to the life sciences industry, developing and manufacturing high-performance enzymes and reagents that support biotechnology innovation worldwide. Today, NEB combines deep enzymology expertise with robust quality systems to support customers who are developing and manufacturing genetic medicines, including mRNA therapeutics, RNA vaccines, DNA vaccines, gene editing therapies, viral vectors, and cell and gene therapies. From supporting Operation Warp Speed throughout the pandemic, to the supply of reagents for low- and middle-income (LMIC) vaccine development, NEB has the manufacturing capacity, quality systems and global infrastructure to support genetic medicine programs and advanced therapy medicinal products (ATMPs) from early development through to commercialization.
* “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.
To inquire about GMP-grade reagents
Resources you Might Find Helpful
Webinars
- Utilization of Oxford Nanopore Technologies Direct RNA Sequencing and RNase 4 based LC-MS workflows for mRNA characterization
- Accelerating RNA & DNA Therapeutics with Cell-free DNA Synthesis
- Comprehensive mRNA Characterization by LC-MS/MS using RNase 4
Brochures
eBook
Blog Articles
- An Interview with Dr Craig Martin on the Benefits of a New IVT Platform for RNA Manufacturing
- Cell-free DNA Synthesis for a Faster Path to RNA and DNA Therapeutics
- 8 tips to Follow When Choosing a Restriction Enzyme for In vitro mRNA Transcription for Vaccine and Therapeutics Production
- mRNA Synthesis Democratized with Open-source Approach by BASE Facility Researchers
- Afrigen's Mission to Empower Developing Countries with mRNA Vaccine Production
