Last Updated on: 15th July 2024, 06:37 pm
Upperton Pharma Solutions, a contract development and manufacturing organisation (CDMO), is proud to announce the successful completion of a Medicines and Healthcare products Regulatory Agency (MHRA) inspection at its newly established 50,000 sq ft development and GMP manufacturing facility in Nottingham, UK.
This milestone, carried out by the UK Government’s regulatory body, marks a significant accomplishment for Upperton Pharma Solutions, following the remarkable completion of the facility’s build, commissioning, validation, and approval in just 18 months. With the successful MHRA inspection approval, Upperton Pharma Solutions has enhanced its offerings, supporting the development of oral, nasal, and pulmonary drug products, and is now capable of providing Phase I, II, and III clinical supplies.
Nikki Whitfield, CEO of Upperton Pharma Solutions, remarked: “We are absolutely delighted to achieve this milestone. We have been conducting manufacturing scale-up activities since the start of the year following the installation of the larger-scale solid oral dosage form process trains and this gives the green light for our GMP facility to support clients right through to late-phase clinical manufacture and product registration.”
The successful MHRA inspection enables Upperton Pharma Solutions to transition seamlessly from research and development (R&D) to GMP manufacturing and commercialisation on one site, following recent investments in large-scale process equipment such as the Gerteis Mini-Pactor®, GEA Post Hoist Blender, O’Hara M50 Tablet Coating System, and ZANASI 40 Capsule Filler.
Capable of handling batch sizes up to 250kg and a wide variety of dosage forms, including solids, liquids, semi-solids, nasal, and inhaled pharmaceuticals, as well as potent molecules and controlled drugs, the MHRA approval signifies Upperton’s transition into an integrated CDMO.
Paul Kelsall, Director of Clinical Manufacturing, stated: “This is a dedication to the tremendous hard work our colleagues have put in to achieve the targets and aspirations of our business. We are looking forward to working with our clients and offering services from early-stage development through to late-stage clinical manufacture and product registration. These are exciting times for Upperton as we continue to move forward and expand our capabilities.”
Jon Austwick, Director of Quality & Compliance, added: “This achievement is a culmination of 18 months of hard work to commission a state-of-the-art facility and build the rigorous quality and compliance processes to ensure the highest standards of service to our customers.”
