N4P has announced the appointment of Ardena Holding NV (‘Ardena’) as its contract development and manufacturing organisation (‘CDMO’) partner for the technology transfer and upscaling manufacture of Nuvec®, the Group’s unique silica nanoparticle delivery system.
With focus remaining on the optimisation of Nuvec®’s formulation along with continued generation of data for its advancement and prospective applications, N4P recognised the importance of having access to a highly consistent product across its studies along with the potential to move to GMP certification as and when required.
With the contract divided into three separate stages, Ardena’s multidisciplinary team was selected for its ideally matched range of skills and experiences, along with a rigorous and comprehensive approach to compiling regulatory dossier in a timely/costefficient manner that might best support Nuvec® as it moves toward either partnered or independent clinical development.
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