Nanologica AB has entered into a service agreement with global contract development and manufacturing organization (CDMO) Sterling Pharma Solutions for the large-scale production of silica particles.

The partnership is the latest step in the development of a new business venture for Nanologica, which specializes in the development and manufacture of silica for application in drug delivery and chromatography.

Using Nanologica’s technology, UK-based Sterling Pharma Solutions will produce the large volumes of NLAB Saga chromatography material needed to perform preparative chromatography.

“Sterling has 50 years of experience in cGMP manufacturing for the pharmaceutical industry and a very strong process knowledge,” said Andreas Bhagwani, chief executive officer, Nanologica. “This new partnership will allow us to scale production to completely different volumes than what is possible from our own site in Södertälje, Sweden. In practice, this means that our capacity increases from tens of kilograms to tens of tons.”

Nanologica announced in February 2018 that it will start manufacturing preparatory chromatography media. Preparative chromatography is used in pharmaceutical manufacturing to “purify” peptides, specifically insulin. Greater amounts of silica are used in preparative chromatography than in analytical chromatography, where Nanologica is active today.

“We can now engage in detailed negotiations with two potential customers regarding our preparative chromatography offering,” said Mr. Bhagwani. “The goal is to finalize long-term supply agreements that will provide us with profitability relatively quickly.”

Sterling Pharma Solutions, based in the North East of England, 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 the development and scale-up of complex synthesis in a fully cGMP environment. The combination of the Nanolologica expertise and technology, together with Sterling’s manufacturing capabilities, provides the required combination for successful commercialization.”