Global contract development and manufacturing organization (CDMO), Sterling Pharma Solutions has started large-scale production of Nanologica’s silica particles.
 
Nanologica is a nanotechnology company specializing in the development of silica for application in drug development and chromatography.
 
The company recently signed a long-term supply agreement with Chinese company, Yunbo Technology allowing Sterling to begin production.
 
Using Nanologica’s technology, Sterling will produce the large volumes of NLAB Saga chromatography material needed by Yunbo Technology to perform preparative chromatography with the first batch expected to be ready for testing during 2020.
 
“Sterling has over 50 years of experience in cGMP manufacturing for the pharmaceutical industry and very strong process knowledge and expertise in production,” said Andreas Bhagwani, chief executive officer, Nanologica. “We feel very comfortable about cooperating with them for scaling up production to completely different volumes than what we manufacture at our site in Södertälje.”
 
Nanologica announced in February 2018 that it will start manufacturing preparatory chromatography media used in pharmaceutical manufacturing to “purify” peptides, specifically insulin. Vastly greater amounts of silica are used in preparative chromatography than in analytical chromatography, where Nanologica is active today.
 
The first commercial batch is expected to be delivered by Sterling during 2021.
 
Sterling Pharma Solutions, which has sites in the UK and the U.S., is a well-established manufacturer of active substances, materials and products for customers in the pharmaceutical industry.
 
Kevin Cook, chief executive officer, Sterling Pharma Solutions, said, “Sterling is delighted to be working with Nanologica on this exciting and innovative opportunity. Sterling has rich experience in development and scale-up of complex synthesis in a fully cGMP environment. The combination of the Nanologica expertise and technology, together with Sterling’s manufacturing expertise, provides the required combination for successful commercialization.”
 
Nanologica has assessed the preparative chromatography market and believes there is significant potential for growth. The company is planning to expand its presence and customer base within the field facilitated by the start of large-scale manufacturing and being able to provide larger samples to customers for testing.