Last Updated on: 16th January 2024, 06:44 pm
Upperton Pharma Solutions, a front-running Contract Development and Manufacturing Organisation (CDMO) in the UK, has disclosed a strategic £5 million investment aimed at broadening its operational scope into small-scale sterile fill-finish.
In 2023, after successfully completing the construction and qualification of a new GMP facility spanning 50,000 sqft, the UK-based CDMO is set to further extend its footprint at the Trent Gateway site. This expansion includes the addition of sterile production capabilities within a specially designed facility, aligning with the updated EU GMP Annex-1 standards.
This investment brings an extra 7,000 sqft of sterile manufacturing space to the Trent Gateway location. This expansion comes on the heels of a significant surge in demand for the development and production of sterile and terminally sterilised products.
Nikki Whitfield, CEO of Upperton Pharma Solutions, commented, “This investment tackles a critical shortage in our sector for small-scale sterile drug product suppliers, especially to support initial clinical trials. Given our existing expertise in formulation development and analytical capacities, this move signifies a logical and exciting step forward in Upperton’s growth trajectory.”
The new sterile facility, conforming to the EU GMP Annex-1 Revisions, is set to incorporate cutting-edge VHP isolation technology. It will focus on GMP fill-finish processes for sterile drug products, catering to biologics and small molecules. It takes advantage of the current comprehensive services in formulation development and quality control laboratories. The facility will facilitate the production of aseptic and terminally sterilised small-volume liquids for parenteral, ocular, and pulmonary delivery.
The construction of the facility is slated to commence in February 2024, with the aim of completing commissioning and validation by the early fourth quarter of 2024.
This new venture into sterile drug product manufacturing augments Upperton’s existing services, which encompass formulation development across various dosage forms, clinical trial supply, and niche-scale commercial production for non-sterile dosage forms.
Nikki further stated, “Our executive team thoroughly comprehends the hurdles involved in progressing our clients from pre-clinical stages to early-phase clinical studies, ensuring quality and regulatory adherence. With our leadership’s collective expertise in establishing and operating sterile facilities, we’re poised to confidently venture into this new market segment.”
