Upperton has submitted an application to the UK’s Medicines and Healthcare Products Regulatory Agency for approval of its new 7,000‑square‑foot sterile manufacturing facility in Nottingham. The filing follows completion of aseptic process simulation validation batches performed under the EU’s updated GMP Annex 1 standards.

The site, built to current Eudralex Volume 4 Annex 1 requirements, expands Upperton’s footprint alongside its existing 50,000‑square‑foot development and manufacturing facility. The company said the new plant will support formulation development and production of aseptic and terminally sterilized drug products for parenteral, nasal and pulmonary delivery. Initial batch sizes will reach up to 2,000 units, primarily serving small and mid‑sized biotech firms from preclinical through Phase 2 studies.

“The team has worked tirelessly to achieve this outcome, particularly given the challenging landscape shaped by the updated Annex 1 guidelines,” said CEO Nikki Whitfield. “Everyone involved, across every department, has contributed to building an outstanding sterile manufacturing capability that meets the highest global standards.”

Built amid tighter contamination‑control requirements introduced in the revised Annex 1 framework, the facility includes two Grade C cleanrooms, an Envair Technology three‑chamber isolator, a LAST Technology depyrogenation oven and an LTE Scientific autoclave. Equipment also includes Flexicon aseptic filling technology, advanced HVAC monitoring systems and pre‑use post‑sterilization integrity testing.

Upperton is among the first U.K. CDMOs to design a new sterile facility specifically aligned to the revised Annex 1 expectations. The company said it developed new aseptic manufacturing processes, environmental monitoring systems and operator‑training pathways as part of the build.

The £7 million investment aims to relieve capacity constraints in small‑scale sterile manufacturing, where companies can face delays of more than a year. “We want to give small and mid-sized biotech companies faster access to the high-quality sterile formulation development and manufacturing capacity they need to progress into clinical trials without unnecessary delays,” Whitfield added.

The company also plans to add aseptic spray‑dried powder capability, with a second isolator expected to come online in late 2026.

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