Upperton Pharma Solutions, a contract development and manufacturing organization (CDMO) based in Nottingham, UK, has received approval from the Medicines and Healthcare products Regulatory Agency (MHRA) to manufacture sterile investigational medicinal products at its new Trent Gateway facility.

The approval expands Upperton’s existing Manufacturing and Importation Authorization for Investigational Medicinal Products (MIAIMP) license to cover the new facility, allowing the company to begin GMP production for early-phase clinical trials.

Designed around the revised EU GMP Annex 1 requirements, the 7,000-square-foot facility supports aseptic processing and terminal sterilization for small-scale batches. Equipment includes Grade A isolators, vaporized hydrogen peroxide (VHP) bio-decontamination, dry heat depyrogenation, an autoclave, independent HVAC systems, as well as pre-use post-sterilization integrity testing.

The facility is located alongside Upperton’s existing 50,000-square-foot development and clinical manufacturing site in Nottingham, combining formulation development, analytical testing, nonsterile GMP manufacturing, and clinical drug product manufacturing at one location. Upperton said the new capability is designed for pharmaceutical and biotechnology companies developing small molecule and biologic products in early clinical stages.

The approval follows Upperton’s March application after completion of aseptic process simulation validation batches under the revised Annex 1 requirements. At the time, the company said the £7 million ($9 million) facility would support preclinical through Phase II programs, with initial batch sizes of up to 2,000 units.

The facility is part of Upperton’s investment in its Nottingham operations and expands the CDMO’s development and clinical manufacturing services to include sterile drug products.