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Customized Solutions – Quality & Specifications

With ISO 13485:2003 and ISO 9001:2008 certified facilities in Ipswich, MA, and an additional facility located nearby in Rowley, MA that manufactures GMP-grade* materials, NEB delivers industry-leading product purity and lot-to-lot consistency. Our ISO 13485 certification closely aligns NEB’s quality systems with the principles used by GMP manufacturers. Further, NEB’s QA/QC program exceeds the requirements we have based on ISO 9001 and 13485 quality management standards.

Our Quality Control group is constantly improving the stringency and range of NEB’s quality controls, and we welcome customer-defined quality controls to ensure that every product meets the user’s requirements for their particular application.

 

Learn how we've collaborated with other companies:

When a startup company developing a novel therapeutic manufacturing process needed to scale up their operations, they worked with NEB to optimize their manufacturing process, and ultimately transition production of one of the enzymes used in their process to our GMP-grade facility. Learn more by downloading the case study below.

 

 

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"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. 

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