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 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.

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, sterilization strategies, EM methodologies and personnel qualification pathways.

Paul Kelsall, Director of Clinical Manufacturing, commented: “The strengthening of Annex 1 has raised expectations across all areas of aseptic processing. Our qualification program demonstrates not just compliance, but deliberate technical alignment to the revised regulatory framework.”

Nikki Whitfield, Chief Executive Officer, added: “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 license submission and for supporting our partners’ sterile product development needs.”

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 sterilization
• Terminal moist-heat sterilisation (LTE Scientific autoclave) for sealed product sterilization
• 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 Sterilization Integrity Testing (PUPSIT) has been incorporated to comply with Annex 1 ensuring verification of sterilizing-grade filter integrity before and after processing
• Integrated viable and non-viable environmental monitoring system including continuous airborne particle counting

Jon Austwick, Director of Quality & Compliance, stated: “Our contamination control strategy has been developed as a living, system wide framework linking facility design, equipment capability, process architecture, personnel training and risk management. By integrating isolator technology, continuous environmental monitoring and PUPSIT, we have established a sterility assurance model aligned with the most stringent interpretation of the new Annex 1 expectations.”

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 noted: “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.”

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 specializes 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.

Upperton Pharma Solutions has over 25 years’ experience of delivering science-led, high quality, innovative early drug development solutions to pharmaceutical and biotechnology clients worldwide.

Based in Nottingham, UK, Upperton has formulation and analytical development laboratories, alongside a fully equipped GMP manufacturing and Quality Control testing capability and is licensed by the MHRA to manufacture materials for clinical trial supplies. In addition to supporting conventional oral solid dosage form development, Upperton has a strong history in spray drying which is applied to address both the challenges with poorly soluble molecules and as a particle engineering technology for targeted deposition for pulmonary and nasal drug products. The company employs over 125 highly skilled personnel and has its headquarters in Nottingham, UK.