Upperton submits MHRA application for sterile manufacturing facility in UK
Upperton Pharma Solutions, a contract development and manufacturing organization headquartered in Nottingham, UK, has applied to the Medicines and Healthcare products Regulatory Agency for approval of its 7,000-square-foot sterile manufacturing facility.
The submission follows completion of aseptic process simulation validation batches conducted under the revised EU GMP Annex 1 requirements, said the company. The facility was reportedly designed to meet the updated contamination control framework and will support formulation development and clinical manufacturing of aseptic and terminally sterilized drug products for parenteral, nasal, and pulmonary delivery.
The site includes two Grade C cleanroom manufacturing suites and isolator-based processing equipment intended to support aseptic filling and terminal sterilization. According to the announcement, the facility incorporates a solid wall VHP three-chamber isolator, a dry heat sterilizer depyrogenation oven, and an autoclave for terminal sterilization. Aseptic filling technology and advanced HVAC systems are also used to monitor and control air supply, along with pre-use post-sterilization integrity testing.
Initial production will support small and mid-sized biotech and pharmaceutical companies conducting preclinical through Phase II studies, with batch sizes up to 2,000 units, according to the company.
“The team has worked tirelessly to achieve this outcome, particularly given the challenging landscape shaped by the updated Annex 1 guidelines,” Upperton CEO Nikki Whitfield said in a statement. “Everyone involved, across every department, has contributed to building an outstanding sterile manufacturing capability that meets the highest global standards.”
Upperton said the £7 million ($9 million) investment is intended to address limited small-scale aseptic manufacturing capacity that can delay early-stage clinical programs.
“We want to give small and mid-sized biotechs 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,” Whitfield said.
The facility also includes a Grade C cleanroom designed to house a future isolator for aseptic spray drying to support sterile dry powder drug development, which the company said is expected to come online in the fourth quarter of 2026.
Upperton previously expanded its clinical manufacturing capabilities in October 2025 with the installation of a gravimetric powder filling machine at its Nottingham GMP facility, which the company said improves precision dosing for capsule and device filling used in clinical trial production.