Upperton has received approval from the U.K. Medicines and Healthcare products Regulatory Agency for a variation to its Manufacturing and Importation Authorisation for Investigational Medicinal Products license covering a new sterile manufacturing facility in Nottingham.
The variation extends Upperton’s existing MIA(IMP) license to include the company’s Annex 1-aligned facility at Trent Gateway. The approval allows the company to begin GMP manufacture of sterile investigational medicinal products at the site.
The 7,000-square-foot facility is designed for small-scale GMP batch manufacturing of aseptic and terminally sterilized drug products. It is located next to Upperton’s existing 50,000-square-foot development and clinical manufacturing site in Nottingham.
Upperton said the facility was designed and commissioned in alignment with revised EU GMP Annex 1 requirements. The company said it completed facility construction, qualification, commissioning and aseptic process simulation activities before receiving the license variation.
The sterile facility includes Grade A isolator environments, vaporized hydrogen peroxide bio-decontamination capability, dry-heat depyrogenation, terminal sterilization, aseptic processing, independent HVAC systems and pre-use post-sterilization integrity testing.
Upperton said the site will support formulation development and sterile drug-product manufacturing for early-phase clinical trials. Its existing Nottingham site provides formulation development, analytical testing and nonsterile GMP manufacturing.
The company said the expanded license enables it to provide sterile clinical-supply services from the Nottingham location.
Nikki Whitfield, Upperton’s chief executive officer, said the license variation follows work by the company’s technical, quality and manufacturing teams. Jon Austwick, Upperton’s director of quality and compliance, said contamination-control measures were incorporated into the facility, equipment, processes and operator training.