Nuron Biotech has selected the Merck BioManufacturing Network in the UK to manufacture large-scale GMP clinical supplies of NU100 and undertake process validation leading to long-term commercial operations. NU100 is a proprietary recombinant human interferon beta compound being developed for the treatment of multiple sclerosis (MS).
Nuron Biotech plans to take NU100 into Phase III clinical trials in 2011. The manufacturing process uses a novel large scale pressure refold technology, PreEMT™, which has been installed on the Billingham, UK, site.
“The novel steps in manufacturing that make NU100 unique are important to the success of our product development program,” stated Shankar Musunuri, PhD, MBA, chief executive officer, founder, 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, where NU100 will be manufactured, 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.”
More than 2.1 million people worldwide are thought to be affected by MS, an inflammatory disease of the central nervous system that is often debilitating. Nuron believes that NU100 will be differentiated from other interferon-beta products by virtue of incorporation of PreEMTTM pressure enabled manufacturing process technology that creates a novel interferon beta-1b product that is both free of human serum albumin (HSA) and is essentially free of aggregates.