Upperton Pharma Solutions has formally submitted an application to the Medicines and Healthcare products Regulatory Agency (MHRA) seeking approval for its newly constructed 7,000 sqft sterile manufacturing facility in Nottingham, UK.
The submission follows the successful completion of aseptic process simulation (APS) validation batches performed under the revised requirements of EU GMP Annex 1 (2023).
The requirements introduced stricter controls on contamination risk, facility design and aseptic manufacturing operations.
“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,” said Paul Kelsall, Director of Clinical Manufacturing at Upperton.
Expanding Upperton’s existing site
The new sterile facility expands Upperton’s existing 50,000 sqft pharmaceutical development and manufacturing site in Nottingham and is designed to support formulation development and clinical manufacturing of aseptic and terminally sterilised drug products.
The site will focus on therapies delivered via parenteral, nasal and pulmonary routes.
According to the company, the facility has been built in accordance with Eudralex Volume 4 Annex 1 requirements and incorporates advanced containment and contamination control strategies to meet evolving regulatory expectations.
Initially, the facility will support small and medium-sized biotech and pharmaceutical companies progressing therapies from pre-clinical stages through Phase I and Phase II clinical trials.
The site is configured to manufacture clinical batches of up to 2,000 units while also providing formulation development and analytical testing services.
Containment and cleanroom technologies
The facility incorporates two Grade C cleanroom manufacturing suites, supported by a range of specialised containment and sterilisation technologies designed to maintain product sterility and process integrity.
Key equipment includes a solid wall VHP three-chamber isolator from Envair Technology, alongside a dry heat steriliser depyrogenation oven supplied by LAST Technology and a terminal sterilisation autoclave from LTE Scientific.
Aseptic filling operations are supported by equipment from Flexicon, while advanced HVAC systems independently monitor and control air supply across the cleanroom environment.
Containment specialist Envair Technology designs and manufactures a range of clean air and containment systems, including isolators, laminar airflow cabinets and microbiological safety cabinets used widely in pharmaceutical and laboratory environments.
The company’s rigid isolator systems are designed to protect both operators and sterile products while maintaining controlled environments required for regulated pharmaceutical manufacturing.
Meeting stricter Annex 1 requirements
The project has been delivered against the backdrop of the updated EU GMP Annex 1 guidance, which significantly raises expectations for contamination control strategies, hygienic equipment design and monitoring within sterile manufacturing environments.
In addition to the isolator-based containment approach, the facility also incorporates PUPSIT (Pre-Use Post-Sterilisation Integrity Testing), a process used to confirm filter integrity following sterilisation to help reduce contamination risk during aseptic filling.
The MHRA submission represents the next regulatory step toward bringing the facility fully online, with the site expected to support a growing pipeline of early-stage drug development programmes and clinical trials.
The site is configured to manufacture clinical batches of up to 2,000 units while also providing formulation development and analytical testing services.