NOTTINGHAM, UK. September 17th, 2026 – Upperton, the UK-based contract development and manufacturing organisation (CDMO), has secured approval from the Medicines and Healthcare products Regulatory Agency (MHRA) for a variation to its existing Manufacturing and Importation Authorisation for Investigational Medicinal Products (MIA(IMP)) licence. The approval brings the company’s new Annex 1-aligned sterile manufacturing facility at Trent Gateway, Nottingham, within the scope of the licence.
The approved variation allows Upperton to begin GMP manufacture of sterile investigational medicinal products at the purpose-built facility, extending its integrated development and manufacturing offering to include sterile clinical supply.
Nikki Whitfield, Chief Executive Officer at Upperton, said: “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 with a responsive, high-quality sterile manufacturing service for early clinical development.”
The licence approval marks an important step in Upperton’s strategic expansion and comes after the successful completion of the facility build, qualification, commissioning and aseptic process simulation activities. The approval confirms that the site is ready to manufacture sterile drug products for early-phase clinical trials, giving customers access to flexible, UK-based sterile manufacturing capacity.
The 7,000 sq. ft sterile manufacturing facility has been designed and commissioned in accordance with the revised EU GMP Annex 1 requirements. A comprehensive Contamination Control Strategy has been incorporated from the initial design phase through qualification and into routine operation. Situated alongside Upperton’s existing 50,000 sq. ft development and clinical manufacturing site, the facility strengthens the company’s one-site model for end-to-end drug development. Services available from the Nottingham location include formulation development, analytical testing, non-sterile GMP manufacture and sterile drug product manufacture.
Designed for small-scale GMP batch production, the new facility supports both aseptic processing and the manufacture of terminally sterilised drug products. Its capabilities are intended to meet increasing demand from innovators developing complex small molecule and biologic programmes that require responsive sterile fill-finish services. This is particularly relevant for programmes where speed, technical flexibility and close collaboration between development and manufacturing teams are important to progressing towards first-in-human and early clinical studies.
The facility incorporates Grade A isolator environments, VHP bio-decontamination, dry heat depyrogenation, terminal sterilisation, aseptic processing, independent HVAC systems and Pre-Use Post Sterilisation Integrity Testing (PUPSIT). Together, these systems are designed to support effective contamination control, reduce operator intervention in critical processing areas and provide flexibility for early-stage manufacturing programmes.
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 the new authorisation in place, Upperton can now provide customers with an integrated route from formulation development and analytical testing through to GMP sterile clinical manufacture at its Nottingham site. Bringing these capabilities together enables the company to support technical decision-making earlier in development, including the selection of practical manufacturing routes, appropriate product presentations and sterilisation strategies, helping customers manage clinical supply timelines.
The licence approval follows sustained investment by Upperton in its Nottingham operations, including the development of the Trent Gateway site and continued expansion of its GMP manufacturing, analytical and quality infrastructure. The addition of sterile manufacturing represents the latest stage of Upperton’s growth strategy and further strengthens its ability to support pharmaceutical and biotechnology partners with specialist drug development and clinical manufacturing services from the UK.
