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A new GMP facility in Massachusetts will produce enzymes and other reagents for in-vitro diagnostics.
New England Biolabs (NEB) announced plans to build capacity for manufacturing enzymes and other reagents according to GMP standards, the company announced on June 11, 2015. The plans include construction of a new 30,000 ft2 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 of NEB.
NEB’s original equipment manufacturer business unit, NEBsolutions, has been delivering customized manufacturing and packaging solutions to customers for over 25 years. Relying on this experience, the GMP-compliant manufacturing facility will offer a complete solution for biological reagent manufacturing, including fermentation, purification, formulation, filling, and final packaging.
"Our core enzymes, specialized reagents, and full next-generation sequencing (NGS) workflow solutions continue to be leveraged in novel ways by our customers," said John Pelletier, director of NEBsolutions.
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.