Nanologica has entered into a service agreement with the UK contract development and manufacturing organization (CDMO) Sterling Pharma Solutions Ltd for the large-scale production of silica particles. This is an important step in the development of starting a new business venture, manufacture of preparatory chromatography media.

“We can now engage in detailed negotiations with the two potential customers that we have been having discussions with for a long while. The goal is to finalize long-term supply agreements that will provide us with profitability relatively quickly, ” said CEO Andreas Bhagwani.

Nanologica announced in February 2018 that the company is preparing to start operations within a new business, manufacture of preparatory chromatography media. Preparative chromatography is used in pharmaceutical manufacturing to “purify” peptides, in particular insulin. Vastly greater amounts of silica are used in preparative chromatography than in analytical chromatography, where Nanologica is active today.

Sterling Pharma Solutions is a well-established manufacturer of active substances, materials and products for customers in the pharmaceutical industry. Under the agreement, UK based Sterling Pharma Solutions will produce the NLAB Saga™ chromatography material with Nanologica’s technology. The parties estimate that production processes can be scaled up to large volumes with manufacturing at a competitive cost.

“Sterling has 50 years of experience in cGMP manufacturing for the pharmaceutical industry and a very strong process knowledge and expertise in production. It feels safe to cooperate with them when we scale production to completely different volumes than those we manufacture in Södertälje. In practice, this means that our capacity increases from tens of kilograms to tens of tons, “said Andreas Bhagwani.

“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 Nanolologica expertise and technology, together with Sterling’s manufacturing expertise, provides the required combination for successful commercialisation.” said Kevin Cook CEO Sterling Pharma Solutions.

Nanologica is currently in discussions with two possible customers in preparatory chromatography. These large pharmaceutical manufacturers have positively evaluated trial samples of Nanologica’s materials and received quality documentation. The initiation of production at Sterling is dependent on Nanologica concluding customer contracts to an extent that operations are deemed profitable. Starting large-scale manufacturing production requires certain investments. In view of the strategy to enter the market only when long-term and profitable customer contracts are in place, the ability to secure financing for such investments is expected to be good.