Upperton granted MHRA license for Annex 1 aligned sterile manufacturing facility.

The approved variation enables Upperton to commence GMP manufacture of sterile investigational medicinal products from the purpose-built facility, expanding the company’s integrated development and manufacturing services to include sterile clinical supply.

“Securing this licence is a major achievement for Upperton and reflects the dedication, and technical expertise of our team. 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.” Said Nikki Whitfield, Chief Executive Officer.

The granting of the licence represents a major milestone in Upperton’s strategic expansion and follows the successful completion of facility build, qualification, commissioning and aseptic process simulation activities. It confirms that the site is ready to support the manufacture of sterile drug products for early-phase clinical trials, providing customers access to flexible, UK-based sterile manufacturing capacity.

The 7,000 sq. ft sterile manufacturing facility has been designed and commissioned in alignment with the revised EU GMP Annex 1 requirements, with a comprehensive Contamination Control Strategy embedded from concept through to qualification and routine operation. The facility is located alongside Upperton’s existing 50,000 sq. ft development and clinical manufacturing site, extending the one-site operation that supports end-to-end drug development services. These include formulation development, analytical testing, non-sterile GMP manufacture and sterile drug product manufacture, all from a single UK location.

Built to enable small-scale GMP batch manufacture, the new facility supports the formulation development and manufacture of aseptic and terminally sterilised drug products. The capability meets growing demand from innovators requiring responsive sterile fill-finish services for complex small molecule and biologic programmes. In particular, those where speed, technical flexibility and close development collaboration are essential to progressing into first-in-human and early clinical studies.

The facility is equipped with Grade A isolator environments, VHP bio-decontamination capability, dry heat depyrogenation, terminal sterilisation, aseptic processing, independent HVAC systems, and Pre-Use Post Sterilisation Integrity Testing (PUPSIT). These systems have been selected to support robust contamination control, minimise operator intervention in critical processing zones and provide operational flexibility for early-stage projects.

Jon Austwick, Director of Quality & Compliance at Upperton Pharma Solutions, commented: “The facility has been developed using a Quality by Design approach, with robust contamination control strategies integrated into the facility, equipment, processes and operator training. The granting of this licence reflects the commitment of our quality, manufacturing, engineering, validation, and technical teams in building a facility that is Annex 1 Compliant, scientifically justified and meets current regulatory expectations.”

With this authorisation in place, Upperton can now offer clients an integrated pathway from formulation development and analytical testing through to GMP sterile clinical manufacture all on one site in Nottingham, helping to address demand for flexible, small-batch sterile manufacturing capacity. By bringing sterile capability together with its established formulation development and clinical manufacturing expertise, Upperton can support clients through technical decision-making earlier in development, helping to identify practical manufacturing routes, suitable presentations and appropriate sterilisation strategies before clinical supply timelines become constrained.

The granting of the licence follows a period of sustained investment by Upperton in its Nottingham operations, including the development of the Trent Gateway site and the expansion of its GMP manufacturing, analytical and quality infrastructure. The addition of sterile manufacturing capability represents the next phase in Upperton’s growth strategy and reinforces its commitment to supporting pharmaceutical and biotechnology partners with specialist development and clinical manufacturing services from the UK.