Large-scale production of Nanologica’s silica has now started at the contract manufacturer Sterling Pharma Solutions Ltd. in Newcastle, United Kingdom.
A framework agreement was signed last year, where the terms for starting large-scale production were dependent on Nanologica securing a customer contract for the purchase of silica. Production has now started at Sterling, following the signing in July this year with Chinese Yunbo Technology for a long-term purchase order of silica for preparative chromatography.
Sterling Pharma Solutions is a well-established provider of small molecule API development and manufacturing services to the global pharmaceutical industry. According to the agreement, Sterling will produce the chromatography media NLAB Saga™ using Nanologica’s technology. Technology transfer has been ongoing for some time which has reduced the time for starting up production. The production has now begun and the first delivery of material for testing is expected during 2020, after which the first commercial products are expected during 2021.
“Sterling has over 50 years of experience in cGMP manufacturing for the pharmaceutical industry and a very strong process knowledge and expertise in production. We feel very comfortable about cooperating with them for scaling up production to completely different volumes than what we manufacture in Södertälje” says Andreas Bhagwani, CEO of Nanologica.
“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” says Kevin Cook, CEO of Sterling Pharma Solutions.
Nanologica assesses the potential within the preparative chromatography field to be large. The company intends to engage further customers within this field, a process that is facilitated by the start of large-scale manufacturing and being able to provide larger samples to customers for testing.
For further information, please contact:
Andreas Bhagwani, CEO Nanologica
Ph: +46 70 316 17 02 or e-mail: firstname.lastname@example.org
About Sterling Pharma Solutions Ltd.
Sterling Pharma Solutions Ltd (SPSL) opened in 1969 and provides Contract Development and Manufacturing services. The Dudley site produces clinical trial and commercial quantities of API (Active Pharmaceutical Ingredients) product from grams to tonnes per annum. The site is spread over an area of 169,000 sq. metres and is approved by MHRA (Medical Health Regulatory Authority), PDMA and FDA approved.
About Nanologica AB (publ)
Nanologica was founded in 2004 and is a nanotechnology company developing nanoporous silica particles for applications within life science. Nanologica is world-leading in controlling the shape, size and type of porosity of silica particles. This knowledge is applied within drug delivery and chromatography (a separation technique used in drug development and drug production). The company’s mission is to contribute to better and cheaper treatments for patients worldwide through the technology platform NLAB Silica™. Nanologica’s stock (NICA) is listed on Spotlight Stock Market. For further information, please visit www.nanologica.com.