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.
Upperton
Untitled design - Upperton-Pharma-Solutions-Sterile-Facility-2
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 is in addition to Upperton’s existing 50,000 sq. ft development and clinical manufacturing site and is designed to support early-phase (Phase 1-2) sterile drug product manufacturing across drug products for parenteral, nasal, and pulmonary administration. The facility is designed for small-scale GMP batch sizes up to 2,000 units, supporting clients from pre-clinical development through clinical supply.
Among the First UK CDMOs Submitting Under the Revised Annex 1 Framework Upperton is one of the first UK CDMOs to bring forward a sterile facility built entirely against the revised Annex 1 requirements, requiring new aseptic workflows, sterilisation strategies, EM methodologies and personnel qualification pathways.
Paul Kelsall, director of Clinical Manufacturing, said: “The strengthening of Annex 1 has raised expectations across all areas of aseptic processing. Our qualification programme demonstrates not just compliance, but deliberate technical alignment to the revised regulatory framework.”
Nikki Whitfield, chief executive officer, said: “Every aspect of this facility has been built with contamination control as the top priority. We are confident that our Contamination Control Strategy driven approach provides a robust technical foundation for our licence submission and for supporting our partners’ sterile product development needs.”
Contamination control strategy embedded from concept to APS execution
The facility has been designed around a comprehensive Contamination Control Strategy (CCS), developed in alignment with Annex 1 and structured around risk-based principles.
- Two GMP Grade A isolator environments within Grade C cleanroom suites
- Solid-wall VHP three chamber isolator (Envair Technology) providing automated bio decontamination cycles and extended sterility assurance levels
- Dry heat depyrogenation (LAST Technology) for high-temperature sterilisation
- Terminal moist-heat sterilisation (LTE Scientific autoclave) for sealed product sterilisation
- Aseptic liquid filling capability (Flexicon) with configurable fill-finish tooling
- Independent HVAC supply and return systems with real-time differential pressure, temperature, humidity, and particle monitoring
- Pre-Use Post Sterilisation Integrity Testing (PUPSIT) has been incorporated to comply with Annex 1 ensuring verification of sterilising-grade filter integrity before and after processing
- Integrated viable and non-viable environmental monitoring system including continuous airborne particle counting
Expanding UK sterile clinical manufacturing capacity
Upperton’s £7 million sterile facility addresses known constraints in the UK and EU sterile fill finish market, particularly for early-phase niche batch sizes. Long lead times, commonly 12 to 18 months, remain a bottleneck for emerging biopharma companies requiring sterile formulation, filling, and clinical supply.
CEO Nikki Whitfield said: “Our investment directly addresses capacity shortages for small-scale sterile manufacturing. By designing a facility capable of rapid technology
transfer, flexible batch configuration, and Annex 1 compliant aseptic processing, we aim to accelerate clinical timelines for small and mid-sized innovators.”
Future aseptic spray-drying capability
The facility includes a dedicated Grade C cleanroom engineered for future aseptic spray-drying operations expected Q4 2026. This expansion will enable sterile dry powder development and manufacturing, leveraging Upperton’s extensive spray drying experience.
Upperton Pharma Solutions is a CDMO that specialises 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.