Merck is conducting large scale good manufacturing practice (GMP) compliant production of NU100, a recombinant human interferon beta for treating multiple sclerosis. Using pressure enabled manufacturing creates a product free of HAS and essential free of aggregates.
”The novel steps in manufacturing that make NU100 unique are important to the success of our product development programme”, said Shankar Musunuri, CEO and founder of Nuron Biotech.
Merck has installed the large scale pressure refold technology, PreEMT, at its production site in Billingham, UK. Process validation leading to long-term commercial operations will also be performed by Merck.