Nanologica AB has within the project with Vicore Pharma been assigned to commence preparative work for the manufacturing of GMP classified material. The agreement is worth up to MSEK 8.
The VP02 project aims to deliver an API locally in the lung by formulating it using Nanologica’s technology platform for inhalation, NLAB Spiro™. The platform is constituted of biologically degradable nanoporous microspheres that can be loaded with APIs. The method can potentially maximize the uptake of the drug locally, while minimizing the effects on the rest of the body.
According to the agreement, Nanologica will lead the process of manufacturing GMP classified material. The manufacturing will take place at the contract manufacturer Sterling Pharma Solution, whose production plant is GMP certified. Nanologica will lead technology transfer of the Company’s technology to Sterling Pharma Solutions, as well as verify the manufacturing method in industrial scale.
” The project with Vicore Pharma is highly interesting and advances towards clinic as a result of the GMP manufacturing process starting up. This continued trust validates the potential we see in our drug delivery platform and we look forward to taking on the task”, says Andreas Bhagwani, CEO of Nanologica.
The agreement is divided into two phases, where the first phase is related to technology transfer and verification of the manufacturing process. After the first phase is approved, the second phase constituting of production will commence. The agreement relates to the press release dated January 28, 2020, in which Nanologica announced that final negotiations with a pharma company had begun.
For further information, please contact:
Johanna Johansson, IR Nanologica
Ph: +46 72 211 21 90 or e-mail: firstname.lastname@example.org
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 development 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.
About NLAB Spiro™
NLAB Spiro™ is Nanologicas technology platform for inhalation. The platform is constituted of biologically degradable nanoporous microspheres that can be loaded with APIs. The microspheres are between 2 µm and 5 µm with a tight size distribution, which means they can reach a desired part of the lung. The microspheres are non-aggregating and appears as a free-flowing powder suited for inhalation. The particles dissolve in simulated lung fluid and have a high loading capacity. NLAB Spiro™ can improve solubility and/or the bioavailability of an API, protect an API from degradation, and provide a controlled release profile, which enables new treatment options for lung diseases.
GMP, (Good Manufacturing Practice) is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product, and to prevent contaminations and mix-ups as well as enabling full traceability of raw materials, packing material and end product.