With the goal of better serving its customers in more regulated markets, New England Biolabs (NEB®) has announced plans to build capacity for manufacturing enzymes and other reagents according to good manufacturing practices (GMP), which are standards for materials involved in the manufacture of human therapeutics and molecular diagnostics. The plans include the construction of a new 30,000 s.f., state-of-the-art, fully GMP-compliant cleanroom facility, to be located near NEB’s Ipswich, MA headquarters. Construction is scheduled to begin in 2015, and the site is expected to be commissioned, validated and fully operational by early 2017.
“Our customers are evolving, and we’re continually improving our manufacturing processes to help these customers achieve their goals. By moving towards GMP compliance, we are giving our customers the confidence that they will be able to continue to rely on our products for their molecular diagnostics materials needs, as they prepare for the future,” said Jim Ellard, CEO.
NEB’s OEM business unit, NEBsolutions®, has been delivering customized manufacturing and packaging solutions to customers for over 25 years. Relying on this extensive experience, the GMP-compliant manufacturing facility will offer a complete solution for biological reagent manufacturing, including fermentation, purification, formulation, filling and final packaging.
“Since the late ‘90s, NEB has proudly served molecular diagnostics customers, and met their needs for supply of critical reagents. Our core enzymes, specialized reagents and full next-generation sequencing (NGS) workflow solutions continue to be leveraged in novel ways by our customers. We believe our increased commitment to the regulatory compliance needs of our customers will enhance these partnerships, while bringing NEB closer to the clinic,” said John Pelletier, Director of NEBsolutions.
Manufacturing reagents of the highest quality, NEB currently holds ISO13845 and ISO9001 Quality Management Systems certifications at its headquarters in Ipswich, MA, and will continue to maintain these standards for its research-use products.