CDMO Upperton Pharma Solutions has received approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA) to begin GMP manufacture of sterile investigational medicinal products at its newly commissioned facility in Nottingham. The regulatory approval comes through a variation to Upperton’s existing Manufacturing and Importation Authorization for Investigational Medicinal Products (MIA(IMP)). It extends the authorization to cover the company’s new sterile manufacturing operation at Trent Gateway.

The approval allows Upperton to add sterile clinical supply to its existing development and manufacturing offering, giving pharmaceutical and biotechnology companies access to small-scale sterile manufacturing capabilities within its Nottingham operations. According to Upperton, the 7,000-sq.ft. facility was developed in accordance with the revised EU GMP Annex 1 framework, with contamination control incorporated throughout the facility’s design, qualification and operating strategy.

“The revised Annex 1 framework has significantly raised expectations across sterile manufacturing, and we are proud to have developed a facility that places contamination control, quality and patient safety at the center of its design,” says Nikki Whitfield, Chief Executive Officer of Upperton.

The company said the facility is intended to support sterile drug product programs from formulation development through early clinical manufacture, with particular relevance to projects progressing towards first-in-human studies and other early-stage clinical trials. The new operation was commissioned following completion of construction, qualification and aseptic process simulation activities. Its design incorporates a comprehensive Contamination Control Strategy, which Upperton said was developed from the initial facility concept through to qualification and routine operation.

Among the facility’s capabilities are Grade A isolator environments, vaporized hydrogen peroxide (VHP) bio-decontamination, dry-heat depyrogenation and terminal sterilization. The site also incorporates aseptic processing, dedicated HVAC systems and Pre-Use Post Sterilization Integrity Testing (PUPSIT). The combination of these technologies is designed to reduce operator intervention in critical processing areas while providing flexibility for different early-stage manufacturing programs, says Whitfield.

The sterile facility sits alongside Upperton’s existing 50,000 sq. ft development and clinical manufacturing site in Nottingham. The expansion brings sterile manufacturing into the same location as the company’s formulation development, analytical testing and non-sterile GMP manufacturing activities. Upperton says the single-site model is intended to give clients a more integrated route through development and clinical supply, allowing formulation, analytical and manufacturing considerations to be addressed earlier in a program.

The new facility has been configured for small-scale GMP batch production of both aseptically processed and terminally sterilized products. Upperton said this capability is aimed at developers working on complex small-molecule and biologic programs, where manufacturing flexibility and rapid progression into clinical studies are important considerations. The company also expects the expanded capability to support decisions around manufacturing routes, dosage-form presentation and sterilization strategies before clinical supply schedules become more constrained.

For more information, visit www.upperton.com.