N4 Pharma Plc (LON:N4P), the specialist pharmaceutical company developing, a novel delivery system for cancer treatments and vaccines, announces that it has appointed the API and Nanomedicines business unit of Ardena as its contract development and manufacturing organisation partner for the technology transfer and upscaling manufacture of Nuvec®.
The contract is divided into three stages:
- Establishing an understanding of the current manufacture process, scale-up and analysis of the transfer of technology;
- Process optimisation and scale-up resulting in the manufacture and analysis of a non-GMP 50g batch of Nuvec®;
- Manufacture, testing and product certification of Nuvec® for GMP status
The manufacture will initially be for the fundamental “naked” Nuvec® silica nanoparticles albeit Ardena has the ability to produce functionalised particles as may be required by the Company or any collaborators from time to time.
Ardena is a CDMO based in the Netherlands with substance and drug product manufacturing capability and is experienced in the manufacture of nanoparticles (liposomes, PLGA micro and nanospheres, silica nanoparticle) which is of particular relevance for Nuvec®. Ardena also has a GMP manufacturing, analytical and product release capability.
Nigel Theobald, N4 Pharma Chief Executive Officer, commented: “We are delighted to be working with Ardena as our tech transfer and manufacturing partner. As we look to continue the advancement of Nuvec® and its applications it is increasingly important that we have access to a consistent Nuvec® product across our studies together with the potential to move to GMP certification as and when required and Ardena can provide this.”