Upperton Gains MHRA Approval for Nottingham Sterile Manufacturing Site

The Medicines and Healthcare products Regulatory Agency (MHRA) has approved a variation to Upperton’s existing Manufacturing and Importation Authorization for Investigational Medicinal Products (MIA(IMP)) license, extending the authorization to the company’s new sterile manufacturing facility at Trent Gateway in Nottingham.

The approval brings the Annex 1-aligned facility under Upperton’s MIA(IMP) license and enables the company to begin GMP manufacture of sterile investigational medicinal products for early-phase clinical trials.

“Securing this license is a major achievement for Upperton and reflects the dedication, and technical expertise of our team,” said Nikki Whitfield, CEO. “The revised Annex 1 framework has significantly raised expectations across sterile manufacturing, and we are proud to have developed a facility that places contamination control, quality and patient safety at the centre of its design. This approval is one of the first of its kind in the UK, enabling us to provide emerging biotech and with a responsive, high-quality sterile manufacturing service for early clinical development.”

The license variation follows completion of the facility build, qualification, commissioning and aseptic process simulation activities. It confirms the site is ready to manufacture sterile drug products for clinical use and adds flexible, UK-based sterile capacity to Upperton’s existing development and clinical manufacturing services.

The 7,000 sq. ft facility was designed and commissioned in line with revised EU GMP Annex 1 requirements, with a comprehensive Contamination Control Strategy embedded from concept through qualification and routine operation. It sits alongside Upperton’s 50,000 sq. ft development and clinical manufacturing site, expanding the company’s one-site model across formulation development, analytical testing, non-sterile GMP manufacture and sterile drug product manufacture.

Purpose-built for small-scale GMP batch manufacture, the facility supports formulation development and manufacture of aseptic and terminally sterilized drug products. The capability addresses demand from innovators needing flexible sterile fill-finish services for complex small molecule and biologic programs moving into first-in-human and early clinical studies.

Key features include Grade A isolator environments, VHP bio-decontamination capability, dry heat depyrogenation, terminal sterilization, aseptic processing, independent HVAC systems and Pre-Use Post Sterilization Integrity Testing (PUPSIT). Together, these systems are intended to strengthen contamination control, limit operator intervention in critical processing areas and provide flexibility for early-stage projects.

With the authorization in place, Upperton can now offer customers an integrated pathway from formulation development and analytical testing through to GMP sterile clinical manufacture at a single Nottingham site. The expanded capability is expected to help relieve demand for flexible, small-batch sterile manufacturing while allowing earlier decisions on manufacturing routes, product presentations and sterilization strategies before clinical supply timelines become constrained.