Upperton Pharma Solutions, a contract development and manufacturing organisation has announced the successful completion of a Medicines and Healthcare products Regulatory Agency (MHRA) inspection at its newly commissioned 50,000 sqft development and GMP manufacturing facility in Nottingham, UK.
This milestone inspection, conducted by the UK Government’s regulatory authority, marks a significant achievement for Upperton Pharma Solutions following the completion of the build, commissioning, validation and approval of the facility in just 18 months.
With the successful MHRA inspection approval, Upperton Pharma Solutions has further enhanced its offering, supporting the development of oral, nasal, and pulmonary drug products underpinned by the capability to provide Phase I, II, and III clinical supplies.
Build, commissioning, validation and approval of the facility occurred in just 18 months
Nikki Whitfield, CEO of Upperton Pharma Solutions, said: “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 seamlessly transition from research and development (R&D) to GMP manufacturing and commercialisation on one site, following recent investment in large-scale process equipment including a Gerteis Mini-Pactor (registered trademark), GEA Post Hoist Blender, O’Hara M50 Tablet Coating System and a ZANASI 40 Capsule Filler.
Capable of handling batch sizes of up to 250kg and a wide variety of dosage forms, such as solids, liquids, semi-solids, nasal and inhaled pharmaceuticals, including potent molecules and controlled drugs, the MHRA approval signals Upperton’s transition into an integrated CDMO.
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
Paul Kelsall, Director of Clinical Manufacturing, commented on the achievement, stating: “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.”
Top image: The GMP manufacturing facility of Upperton Pharma Solutions Video: A tour of The GMP manufacturing facility of Upperton Pharma Solutions
