Upperton has formally submitted its application to the UK Medicines and Healthcare Products Regulatory Agency (MHRA) for approval of its 7,000 sq. ft sterile manufacturing facility. This submission follows the successful completion of aseptic process simulation (APS) validation batches executed under the stringent requirements of the revised EU GMP Annex 1 (2023) requirements.

The facility, built to the current Eudralex Volume 4 Annex 1 requirements with advanced containment control strategies, is in addition to an existing 50,000 sq. ft development and manufacturing facility in Nottingham, UK, and will support the formulation development and manufacturing of aseptic and terminally sterilized drug products for parenteral, nasal and pulmonary drug delivery.

The facility supports small and medium sized biotech and pharmaceutical companies from pre-clinical to phase 1 and phase 2 clinical studies with formulation development, clinical manufacture and analytical testing, with initial batch sizes 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.

Contamination Control Process Design

The build, validation and commissioning of the facility have taken place against the backdrop of the revised EU GMP Annex 1 requirements. The updated guidance sets significantly higher standards across the hygienic design of facilities and equipment and introduces a much more rigorous approach in terms of contamination controls.

The facility includes two Grade C cleanroom manufacturing suites, alongside an Envair Technology Solid Wall VHP Three-Chamber Isolator, LAST Technology Dry Heat Sterilizer Depyrogenation Oven and LTE Scientific Autoclave (terminal sterilization). With aseptic filling technology equipment from Flexicon, advanced HVAC systems to independently monitor and control air supply, and PUPSIT (Pre-Use Post Sterilization 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.”

Among the first UK CDMO facilities aligned to new Annex 1 requirements

With the updated Annex 1 requirements introducing significantly enhanced expectations for contamination control, Upperton is among the first UK CDMOs to bring forward a facility designed specifically to comply with the new framework.

For companies bringing new sterile facilities online, the Annex 1 revisions pose both opportunities and operational hurdles. Upperton embraced this challenge from the outset, investing not only in state-of-the-art facility design but also in the creation of numerous new aseptic manufacturing processes tailored specifically to align with Annex 1’s heightened requirements. This included developing robust contamination control strategies, designing new sterilization and decontamination workflows, implementing advanced environmental monitoring systems, and introducing enhanced operator training and qualification pathways.

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”.

Providing much-needed clinical-scale sterile capacity

The £7 million investment directly addresses a significant bottleneck in the sterile CDMO sector, where lack of small-scale aseptic manufacturing capacity can create delays of 12–18 months for emerging biopharma companies. Upperton’s new sterile capability is designed to ease these pressures by offering flexible, responsive manufacturing options for niche, early-phase clinical projects.

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.”

Future aseptic spray-dried powder capability

In addition to its sterile filling capabilities, the new facility includes a dedicated Grade C cleanroom designed to house a second isolator for future aseptic spray drying, further leveraging Upperton’s long-standing expertise in spray-dried particle engineering to support sterile dry powder development and manufacture, expected Q4 2026. Upperton Pharma Solutions is a CDMO that specializes in formulation development and clinical trial manufacturing across various dosage forms, including oral solids, liquids, semi-solids, and inhalation drug products, from its headquarters in Nottingham, UK.