Upperton has submitted an application to the UK Medicines and Healthcare Products Regulatory Agency (MHRA) seeking approval for its newly developed 7,000 sq. ft sterile manufacturing facility. The submission follows the successful completion of aseptic process simulation (APS) validation batches carried out in accordance with the revised EU GMP Annex 1 (2023) guidelines.
The new facility has been constructed in line with the latest Eudralex Volume 4 Annex 1 standards and incorporates advanced containment and contamination control strategies. It complements Upperton’s existing 50,000 sq. ft development and manufacturing site in Nottingham and will support formulation development and manufacturing for aseptic and terminally sterilised medicines intended for parenteral, nasal and pulmonary delivery.
The facility is designed to support small and medium-sized biotechnology and pharmaceutical companies from pre-clinical development through phase 1 and phase 2 clinical trials. Services will include formulation development, clinical manufacturing and analytical testing, with initial production runs of up to 2,000 units.
“The team has worked tirelessly to achieve this outcome, particularly given the challenging landscape shaped by the updated Annex 1 guidelines. Everyone involved, across every department, has contributed to building an outstanding sterile manufacturing capability that meets the highest global standards. We are extremely proud of what has been achieved.” said Nikki Whitfield, Chief Executive Officer at Upperton.
The facility’s design, validation and commissioning have taken place in parallel with the introduction of the updated EU GMP Annex 1 regulations. The revised framework significantly raises expectations around hygienic facility design and introduces a more comprehensive approach to contamination control.
The new site includes two Grade C cleanroom manufacturing suites alongside specialist equipment such as an Envair Technology Solid Wall VHP Three-Chamber Isolator, a LAST Technology Dry Heat Sterilizer Depyrogenation Oven and an LTE Scientific Autoclave for terminal sterilisation. It also incorporates aseptic filling systems from Flexicon, advanced HVAC infrastructure to independently manage airflow, and PUPSIT (Pre-Use Post Sterilisation Integrity Testing).
Jon Austwick, Director of Quality & Compliance, said: “The facility has been built with a Quality by Design approach, embedding the highest contamination control strategies throughout.”
With the enhanced requirements introduced by the updated Annex 1 framework, Upperton is among the first UK contract development and manufacturing organisations (CDMOs) to establish a facility designed specifically to meet the revised regulatory standards.
For companies developing new sterile manufacturing capabilities, the Annex 1 changes present both opportunities and operational challenges. Upperton approached the project by investing in advanced facility design while developing new aseptic manufacturing procedures aligned with the stricter regulatory expectations. These efforts included implementing comprehensive contamination control systems, establishing updated sterilisation and decontamination processes, deploying advanced environmental monitoring technologies, and introducing strengthened training and qualification programmes for operators.
Paul Kelsall, Director of Clinical Manufacturing, said: “Working with key partners we’ve been able to qualify our facility with expert decision-making and the highest quality at the forefront of our design and processes. I’m excited to see the facility ready for the next steps”.
The £7 million investment aims to address a recognised capacity shortage within the sterile CDMO sector, where limited availability of small-scale aseptic manufacturing can delay projects for emerging biopharmaceutical companies by 12 to 18 months. Upperton’s new facility is designed to reduce these bottlenecks by providing flexible manufacturing capacity for early-phase clinical programmes.
Nikki Whitfield adds: “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. This facility is a major part of that commitment.”
Alongside sterile filling capabilities, the facility includes a dedicated Grade C cleanroom space intended to house a second isolator for future aseptic spray drying operations. This development will build on Upperton’s established expertise in spray-dried particle engineering to support sterile dry powder formulation development and manufacturing, which is expected to be introduced in the fourth quarter of 2026.
Upperton Pharma Solutions is a contract development and manufacturing organisation specialising in formulation development and clinical trial manufacturing across multiple dosage forms. From its headquarters in Nottingham, the company supports projects involving oral solids, liquids, semi-solids and inhalation drug products.
