Approval for New Clinical Manufacturing Site
News Jul 18, 2013
UK-BASED contract research and manufacturing organization Molecular Profiles has opened the doors of its new facility following a successful inspection from the Medicines and Healthcare products Regulatory Agency (MHRA).
The Nottingham-based, £9 million pharmaceutical production site will give drug development companies across the world access to the clinical manufacturing capabilities.
Designed to handle a range of non-sterile dosage forms such as solids, liquids, semi-solids and inhaled products, Molecular Profiles’ new 30,000sq ft. facility marks a significant expansion for the company that started life as a spin-out from Nottingham University over 15 years ago.
The investment adds six GMP suites, new laboratories and a dedicated clinical packing area to support clients’ 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.
Nikin Patel, CEO at Molecular Profiles, said: “Receiving our license 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 high-profile visit from the Honourable Nick Clegg, Deputy Prime Minister of the UK Government, which provided £1.6m to the expansion through the regional growth fund grant.
The company’s vice president Steve Kemp added: “We have enjoyed a sustained and gradual period of growth over the last decade driven by our consulting, formulation development and analytical services but we are expecting our expanded manufacturing facilities to take us to the next level by helping us better compete on a global scale.”
Having a dedicated manufacturing site complements Molecular Profiles’ established formulation development expertise.
Furthermore, it supports its strategic alliance with Onyx Scientific, which is aimed at delivering end-to-end pharmaceutical development services from initial drug discovery through to the later phases of clinical development.
Founded by a group of scientists, Molecular Profiles now works with leading pharmaceutical companies across the globe and specializes in advanced characterization, R&D and manufacturing services.