Molecular Profiles receives MHRA approval for clinical manufacturing

Contract research and manufacturing organisation opens its new £9m facility in Nottingham

Nikin Patel, CEO at Molecular Profiles, said receiving MHRA approval is a big milestone for the company

UK-based contract research and manufacturing organisation (CRMO) Molecular Profiles has opened the doors of its new facility following a successful inspection from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA).

The £9m pharmaceutical production site in Nottingham will give drug development companies across the world access to the state-of-the-art clinical manufacturing capabilities. It marks a significant expansion for the company that started life as a spin-out from Nottingham University more than 15 years ago.

The new 30,000ft2 facility will handle a range of non-sterile dosage forms such as solids, liquids, semi-solids and inhaled products. The investment has added six GMP suites, new laboratories and a dedicated clinical packing area to support Phase I and II clinical trial projects.

The facility also allows for the manufacture of highly potent compounds up to OEB 4 level with manufacturing batch scale of up to 30kg.

Receiving our licence from the MHRA for our new site is probably the biggest milestone for our business since we set-up shop

Nikin Patel, CEO at Molecular Profiles, said: ‘Receiving our licence from the MHRA for our new site is probably the biggest milestone for our business since we set-up shop so is naturally a very exciting time for everyone involved.

‘From a commercial perspective, we are very much open for business and have already received significant interest from companies looking to use our manufacturing capabilities to assist with their clinical trial requirements.’

The official approval of the company’s cGMP-compliant facility follows a recent visit from Deputy Prime Minister Nick Clegg, after the UK government provided £1.6m for the expansion through a regional growth fund grant.

Having a dedicated manufacturing site complements Molecular Profiles’ established formulation development expertise. Furthermore, it supports its alliance with Onyx Scientific, which aims to deliver pharmaceutical development services from initial drug discovery through to the later phases of clinical development.

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