At V-Nano’s, we use the best technologies available for nano-formulated products in sterile environment. Not all technologies are suited for current good manufacturing practices (cGMP) production. This is often a major obstacle to a trouble-free transition from the ones used by customers to ones which can fit both GMP requirements and our customer needs. In order to do so, at V-Nano we developed a set of activities which can fit all. V-Nano’s in-house lab-scale development and pilot-scale capacities are in place for the development of your processes from discovery to pre-clinical and clinical phases, all this through a team of highly qualified scientists who have been involved in the Nanotechnology Enabled Products (NEP) for decades. We are responsible for the characterisation of your molecule and the NEP you intend to use for clinical supply.
We move your process from design to concrete manufacturing phase ensuring, throughout the process, the highest quality standards to meet the cGMP requirements.
Once your process is lab-scale enabled, V-Nano pilot-scale NEP laboratory takes the lead to provide you with the required product quantities for your clinical supply, and to further upscale the production process.
Finally, V-Nano uses a unique cGMP platform to supply quantities of up to 60 litres of NEP in fully sterile environment. This platform was built for late-stage clinical phase and commercial supply for orphan drugs. We procced to transfer, in sterile conditions, fully formulated NEP to the primary filling step.
There is no need to transfer your highly value product to a second location: V-Nano built a full integrated process for your benefit and that of your product.
A state-of-the-art sterile filling line under isolator is included in our offer; we transfer formulated NEP to our new isolated filling line located within our facility to fill your product in 6 log sterility assurance environment.
This layout is unique to V-Nano and cannot be found elsewhere in the world!