N4 Pharma chooses Ardena as contract manufacturing partner

Specialist pharmaceutical company N4 Pharma 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’, it announced on Tuesday.

The AIM-traded firm said the contract was divided into three stages, with the first being establishing an understanding of the current manufacturing process, scale-up and analysis of the transfer of technology.

It said the second phase would see process optimisation and scale-up, resulting in the manufacture and analysis of a non-GMP 50g batch of Nuvec, with the third phase being the manufacture, testing and product certification of Nuvec for ‘Good Manufacturing Practice’ (GMP) status.

The manufacture would initially be for the fundamental "naked" Nuvec silica nanoparticles, although Ardena has the ability to produce functionalised particles as could be required from time to time, the board said.

N4 described Ardena as a contract development and manufacturing organisation based in the Netherlands, with substance and drug product manufacturing capability.

It said it was experienced in the manufacture of nanoparticles, which was of particular relevance for Nuvec.

Ardena also has a GMP manufacturing, analytical and product release capability.

“We are delighted to be working with Ardena as our tech transfer and manufacturing partner,” said chief executive officer Nigel Theobald.

“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.”

At 1553 BST, shares in N4 Pharma were up 4.3% at 12.12p.