Sonazoid is a world leading contrast agent for medical ultrasound (US) imaging comprising microbubbles, and is currently manufactured as a freezedried product, meaning that the end user (hospital nurse or pharmacy) has to reconstitute the product with water prior to use. Furthermore, the freezedrying process is lengthy (limiting manufacturing capacity), costly and also entails the emission of a powerful greenhouse gas. The primary objective of the current project is to develop and obtain regulatory approval for a Ready-to-Use, liquid formulation of Sonazoid, with the aim of providing a very significant increase in manufacturing capacity, a reduction in emission of green-house gases, a reduction in manufacturing costs and a more user friendly product.
Providing a liquid formulation of microbubbles which is stable under prolonged storage is not straight forward, and requires extensive R&D with regards to formulation and manufacturing aspects.
The first year of the project comprises an extensive pre-formulation and screening phase, where a range of formulations will be made and screened for storage stability, measured as key product characteristics. The end-point of this phase will be to select the 2-3 most promising formulation candidates for further evaluation in the next, lead-selection phase where a final lead candidate will ultimately be chosen for full development.
Sonazoid is a world leading contrast agent for medical ultrasound (US) imaging, currently manufactured at GE Healthcare AS (Norway) as a freezedried product. It is also a primary component in PS101, a therapeutic drug product for Acoustic Cluster Therapy, currently being developed by EXACT Therapeutics (Norway) for treatment of solid cancers.
Sales volumes of Sonazoid are forecasted to exceed the current manufacturing capacity at GE Healthcare in the long term future which, hence, needs to be expanded. A range of commercial and environmental benefits with a Ready-to-Use (aqueous) formulation of Sonazoid (RtU-S) has been identified including; a markedly increased manufacturing capacity; a reduced CO2 emission; manufacturing cost savings, and increased user friendliness vs. competitive products.
The current project is hence directed towards developing and documenting RtU-S formulation for ultimate regulatory approval. The project contains 3 phases; a pre-formulation and screening phase in order to identify candidates for further development; a lead-candidate phase where one of these is selected for full development and; full development phase where upscaling is achieved and the necessary regulatory documentation generated. Primary end-points throughout the project will be current regulatory specifications, in addition to in-vitro and in-vivo characterization of US imaging attributes and therapeutic benefit in order to demonstrate biocomparability.
In the partner constellation, GEHC will be project owner and provide R&D related to formulation, manufacture and analyses of RtU-S. EXACT will provide R&D related to US characterization and the use of RtU-S as part of PS101. Academic R&D providers at LabTAU (France) and NTNU (Norway) will generate the necessary biocomparability data.