Firm will make interferon beta product for Phase III and conduct process validation for commercial supply.
Nuron Biotech selected the Merck BioManufacturing Network to produce large-scale GMP supplies of NU100 for an upcoming Phase III multiple sclerosis trial. Merck will also undertake process validation leading to long-term commercial operations.
The manufacturing process will use a large-scale pressure refold technology, PreEMT™. It was licensed from BaroFold last May and has been installed at Merck’s Billingham, U.K. site.
NU100 is a recombinant human interferon beta compound, which Nuron Biotech plans to take into late-stage trials later this year. Nuron says NU100 differs from other interferon-beta products because of PreEMT’s high-pressure protein disaggregation and refolding capabilities. The technology resulted in an interferon beta-1b product free of human serum albumin and essentially free of aggregates.
The manufacturing agreement comes almost two weeks after Nuron announced an agreement with Catalent Pharma Solutions for the formulation and supply of NU100. Nuron, which initiated operations less than a year ago, has established late-stage product programs in three distinct disease areas: central nervous system diseases, wound healing, and vaccines.