- Upperton has received MHRA approval for a variation to its existing MIA(IMP) licence, extending the authorization to its new Annex 1-aligned sterile manufacturing facility at Trent Gateway in Nottingham, UK.
- The 7,000-square-foot facility enables GMP manufacture of sterile investigational medicinal products and expands Upperton’s services to include sterile clinical supply.
Upperton, a UK-based contract development and manufacturing organization (CDMO), has received approval from the Medicines and Healthcare products Regulatory Agency (MHRA) for a variation to its existing Manufacturing and Importation Authorisation for Investigational Medicinal Products (MIA(IMP)) licence. The variation extends the licence to cover the company’s new sterile manufacturing facility at Trent Gateway in Nottingham, enabling GMP manufacture of sterile investigational medicinal products.
The 7,000-square-foot facility has been designed and commissioned in alignment with the revised EU GMP Annex 1 requirements. It supports small-scale GMP batch manufacture of aseptic and terminally sterilized drug products and is intended to provide sterile fill-finish services for complex small-molecule and biologic programs. The facility includes Grade A isolator environments, VHP bio-decontamination, dry heat depyrogenation, terminal sterilization, aseptic processing, independent HVAC systems and Pre-Use Post Sterilization Integrity Testing (PUPSIT).
The sterile facility is located alongside Upperton’s existing 50,000-square-foot development and clinical manufacturing site. Together, the facilities provide formulation development, analytical testing, non-sterile GMP manufacture and sterile drug product manufacture from a single UK location. Upperton said the integrated model is intended to support clients from formulation development through GMP sterile clinical manufacture.
The licence approval follows the completion of facility build, qualification, commissioning and aseptic process simulation activities. Upperton said the facility has been developed using a Quality by Design approach, with contamination control strategies incorporated across the facility, equipment, processes and operator training.
“Securing this licence is a major achievement for Upperton and reflects the dedication, and technical expertise of our team. The facility was designed with contamination control, quality and patient safety at its center and would provide sterile manufacturing services for early clinical development.”
Nikki Whitfield, Chief Executive Officer of Upperton
