Upperton Pharma Solution Passes MHRA Inspection, Simultaneously Invests in Large-Scale Processing
The 50,000 square-foot facility has the ability to handle various batch sizes and dosage forms.
At its 50,000 square-foot development and current good manufacturing practice (cGMP) facility in Nottingham, UK, Upperton Pharma Solutions, a contract development and manufacturing organization (CDMO), has completed a Medicines and Healthcare products Regulatory Agency (MHRA) inspection.1
The inspection follows the completion of the construction, commissioning, validation, and approval of the plant in 18 months, dating back to when Pharma Commerce reported2 on the company breaking ground in January 2023. The result of MHRA inspection provides additional credibility, including through the ability to boost its offerings, via the development of oral, nasal, and pulmonary drug products, specifically by being able to deliver Phase I, II, and III clinical supplies. Upperton has the ability of managing batch sizes of up to 250 kg, along with various dosage forms, including solids, semi-solids, liquids, nasal and inhaled pharmaceuticals.
“We are absolutely delighted to achieve this milestone,” expressed Nikki Whitfield, CEO of Upperton Pharma Solutions. “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.”
Following its 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, Upperton is now able to switch from research and development (R&D) to GMP manufacturing and commercialization, all on one site.
“This is a dedication to the tremendous hard work our colleagues have put in to achieve the targets and aspirations of our business,” noted Paul Kelsall, Upperton’s director of clinical manufacturing. “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.”
And according to Jon Austwick, the CDMO’s director of quality & compliance, “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.”
Separately, the company decided to further grow its Trent Gateway site to now feature sterile services by investing $5.44 million (£5 million) toward a facility that aligns with the revised EU GMP Annex-1 regulations. Specifically, the financial commitment helps erect a 7,000 square-foot sterile manufacturing facility.3
“This investment addresses a real shortage within our industry of providers of small batches of sterile drug products to support early clinical trials.,” said Whitfield. “Given our existing formulation development and analytical capabilities, it represents a natural progression for Upperton and an exciting milestone in our growth plans.”
References
1. Upperton Pharma Solutions Adds Large-Scale Processing following MHRA Approval at Nottingham Facility. Upperton Pharma Solutions. July 16, 2024. Accessed July 16, 2024. https://upperton.com/upperton-pharma-solutions-adds-large-scale-processing-following-mhra-approval-at-nottingham-facility/
2. Upperton Pharma Solutions Begins Construction of GMP Facility. Pharmaceutical Commerce. January 19, 2023. Accessed July 16, 2024. https://www.pharmaceuticalcommerce.com/view/upperton-pharma-solutions-begins-construction-of-gmp-facility
3. Upperton announces expansion into sterile drug manufacturing with new £5million GMP facility. Upperton Pharma Solutions. January 16, 2024. Accessed July 16, 2024. https://upperton.com/upperton-announces-expansion-into-sterile-drug-manufacturing-with-new-5million-gmp-facility/
