Molecular Profiles' New Site Receives MHRA Approval - Pharmaceutical Technology

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Molecular Profiles' New Site Receives MHRA Approval
The new production site is designed to handle a range of non-sterile dosage forms and allow for the manufacture of highly potent compounds.



Molecular Profiles, a contract research and manufacturing organization, announced that it has opened its new facility in the UK following official approval from the Medicines and Healthcare products Regulatory Agency (MHRA). The company has invested £9 million in this new 30,000 square feet pharmaceutical production site based in Nottingham, which has been designed to handle a range of non-sterile dosage forms such as solids, liquids, semi-solids, and inhaled products. The facility also offers manufacturing services for highly potent compounds up to OEB 4 level with manufacturing batch scale of up to 30 kg.

The facility will provide state-of-the-art clinical manufacturing capabilities to drug development companies worldwide, marking a significant expansion for Molecular Profiles after its spin-out from the University of Nottingham more than 15 years ago. There are six GMP suites, new laboratories and a dedicated clinical packing area to support clients' Phase I and II clinical trial projects.

The manufacturing site not only complements Molecular Profiles' established formulation development expertise but also supports the company's strategic alliance with Onyx Scientific, which was formed in August last year and aimed at delivering end-to-end pharmaceutical development services from initial drug discovery through to the later phases of clinical development.

Nikin Patel, CEO at Molecular Profiles, remarked in a press statement that the license from the MHRA for the new site is probably the biggest milestone for the company's business. "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."

Molecular Profiles was founded by a group of scientists and currently works with pharmaceutical companies around the world, providing advanced characterization, R&D and manufacturing services.

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