- Upperton Pharma Solutions has completed an MHRA inspection at their new GMP manufacturing facility in Nottingham, UK.
- The facility, now approved for GMP manufacturing, supports the development of oral, nasal, and pulmonary drug products.
Upperton Pharma Solutions has announced the successful completion of a Medicines and Healthcare products Regulatory Agency (MHRA) inspection at its newly commissioned 50,000 sq ft development and GMP manufacturing facility in Nottingham, UK.
This inspection, conducted by the UK Government’s regulatory authority, marks a significant achievement following the impressive build, commissioning, validation, and approval of the facility in just 18 months. With this approval, Upperton Pharma Solutions enhances its capability to support the development of oral, nasal, and pulmonary drug products and provide Phase I, II, and III clinical supplies.
Nikki Whitfield, CEO of Upperton Pharma Solutions, commented, “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 allows Upperton Pharma Solutions to transition seamlessly from research and development (R&D) to GMP manufacturing and commercialisation on one site. This follows recent investment in large-scale process equipment, including a Gerteis Mini-Pactor ®, GEA Post Hoist Blender, O’Hara M50 Tablet Coating System, and a ZANASI 40 Capsule Filler.
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.”
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. 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.”
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