Upperton has submitted its application to the UK Medicines and Healthcare Products Regulatory Agency (MHRA) for approval of a new 7,000 sq. ft sterile manufacturing facility. The submission follows the successful completion of aseptic process simulation (APS) validation batches conducted in accordance with the updated EU GMP Annex 1 (2023) standards.
Constructed in compliance with the latest Eudralex Volume 4 Annex 1 requirements, the new facility incorporates advanced contamination control measures and containment systems. It will operate alongside Upperton’s existing 50,000 sq. ft development and manufacturing site in Nottingham, supporting the development and production of aseptic and terminally sterilised medicines for parenteral, nasal and pulmonary drug delivery.
The facility has been designed to support emerging 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 batch sizes 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.
Construction, commissioning and validation activities have taken place during a period of regulatory transition following the revision of EU GMP Annex 1. The updated framework sets more demanding requirements for hygienic facility design and strengthens expectations around contamination prevention and monitoring.
The facility features two Grade C cleanroom manufacturing areas together with specialised equipment including 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. Additional systems include Flexicon aseptic filling technology, advanced HVAC infrastructure for precise air management, 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.”
As regulatory expectations for sterile manufacturing increase under the revised Annex 1 guidelines, Upperton is among the early UK CDMOs to introduce a facility designed specifically to comply with the updated framework.
For organisations developing sterile manufacturing capacity, the revised regulations create both new opportunities and operational challenges. Upperton addressed these demands by investing in advanced facility design while introducing new aseptic manufacturing processes tailored to meet Annex 1 requirements. This work included developing detailed contamination control strategies, designing new sterilisation and decontamination procedures, implementing enhanced environmental monitoring technologies and strengthening training programmes for manufacturing personnel.
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 responds to a widely recognised constraint in the sterile CDMO sector, where limited small-scale aseptic manufacturing capacity can delay projects for emerging biopharmaceutical companies by 12 to 18 months. Upperton’s facility is intended to alleviate these constraints by offering flexible manufacturing options tailored to early-stage clinical development.
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.”
In addition to sterile filling operations, the new site includes a dedicated Grade C cleanroom space designed to accommodate a second isolator for future aseptic spray drying activities. This expansion will build on Upperton’s expertise in spray-dried particle engineering and support sterile dry powder formulation development and manufacturing, expected in the fourth quarter of 2026.
Upperton Pharma Solutions operates as a contract development and manufacturing organisation specialising in formulation development and clinical trial manufacturing across multiple dosage forms, including oral solids, liquids, semi-solids and inhalation products from its headquarters in Nottingham, UK.
