Upperton has submitted its application to the UK Medicines and Healthcare products Regulatory Agency (MHRA) for the approval of its new 7,000 sq. ft sterile manufacturing facility. The submission follows the successful execution of multiple aseptic process simulations (APS media-fill batches), completed in accordance with the revised EU GMP Annex 1 (2023) requirements.
The sterile facility complements Upperton’s existing 50,000 sq. ft development and clinical manufacturing site, designed to support early-phase (Phase 1-2) sterile drug product manufacturing for parenteral, nasal, and pulmonary administration. With small-scale GMP batch sizes up to 2,000 units, it aims to assist clients from pre-clinical development through clinical supply.
As one of the first UK CDMOs to establish a sterile facility built entirely against the revised Annex 1 requirements, Upperton has adopted new aseptic workflows, sterilization strategies, and personnel qualification pathways. Paul Kelsall, Director of Clinical Manufacturing, emphasized that the enhanced Annex 1 standards have elevated expectations across aseptic processing, and the qualification program reflects a commitment to technical alignment with the new regulatory framework.
CEO Nikki Whitfield highlighted that the facility prioritizes contamination control, underpinned by a comprehensive Contamination Control Strategy (CCS) aligned with Annex 1. This strategy is structured around risk-based principles, ensuring robust technical foundations for the license submission and support for partners’ sterile product development.
Upperton’s £7 million investment addresses existing constraints in the UK and EU sterile fill-finish market, particularly for early-phase niche batch sizes. With long lead times often posing bottlenecks for emerging biopharma companies, the facility aims to enhance capacity and accelerate clinical timelines for small and mid-sized innovators.
Additionally, the facility is engineered to accommodate future aseptic spray-drying operations expected by Q4 2026, enabling sterile dry powder development and manufacturing. Upperton Pharma Solutions, based in Nottingham, UK, specializes in formulation development and clinical trial manufacturing across various dosage forms, leveraging over 25 years of experience in delivering high-quality, innovative drug development solutions.
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