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news.Nuron Biotech has chosen Merck BioManufacturing Network to manufacture large scale GMP clinical supplies of NU100 and undertake process validation to achieve long-term commercial operations.
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NU100 is a proprietary recombinant human interferon beta compound under development as a potential treatment for multiple sclerosis (MS) and will go into Phase III clinical trials in 2011.
NU100 is manufactured using a novel large scale pressures refold technology, PreEMT available at the Billingham site.
The company believes that NU100 will be differentiated from other interferon-beta products due to the incorporation of PreEMTTM which will create a novel interferon beta-1b product (this will be free of human serum albumin and aggregates).
Nuron Biotech founder and CEO Shankar Musunuri said Merck BioManufacturing Network’s experience and capabilities range matches Nuron’s needs in clinical trial production and commercialization of NU100.
Merck BioManufacturing Network site general manager Steve Bagshaw said their focus was on introducing new technologies and capacity that offered appropriate scales for Nuron’s manufacturing needs.