Merck BioManufacturing To Supply MS Drug

Nuron Biotech, Inc. has selected the Merck BioManufacturing Network in the UK to manufacture large-scale GMP clinical supplies of NU100 and to provide process validation leading to long-term commercial operations. NU100, entering Phase III development, is a recombinant human interferon beta compound being developed for the treatment of multiple sclerosis (MS). The manufacturing process uses PreEMT, a new large-scale pressure refold technology, which has been installed at the Billingham, UK site.

“The novel steps in manufacturing that make NU100 unique are important to the success of our product development program,” said Shankar Musunuri, Ph.D., MBA, chief executive officer and founder of Nuron Biotech. “The experience and breadth of capabilities offered by Merck BioManufacturing Network match our needs in both the clinical trial production as well as commercialization of our unique product for patients with MS.”

Steve Bagshaw, site general manager of the Merck BioManufacturing Network at Billingham, said, “We are delighted that Nuron has chosen to work with us, recognizing our many years of development experience in microbial biologics, our focus on introducing new technologies and our capacity that offers appropriate scales for their manufacturing needs.”