Upperton Pharma Solutions, a premier UK-based Contract Development and Manufacturing Organisation (CDMO), has revealed its £5 million investment plan to venture into the realm of small-scale sterile fill-finish operations.
Following the completion and validation of a new 50,000 sqft GMP facility in 2023, the CDMO announces its further expansion at the Trent Gateway site. This expansion includes a bespoke facility for sterile capabilities, meticulously designed to comply with the revised EU GMP Annex-1 regulations.
The investment involves an additional 7,000 sqft space dedicated to sterile manufacturing at Trent Gateway. This expansion is in response to the escalating demand for the formulation and manufacturing of sterile and terminally sterilised products.
CEO of Upperton Pharma Solutions, Nikki Whitfield, remarked, “This investment directly addresses a notable gap in our industry for small-batch sterile drug product suppliers, particularly for early-stage clinical trials. Our pre-existing strengths in formulation development and analytical skills make this a natural and exhilarating progression for Upperton, marking a key milestone in our expansion plans.”
Designed in compliance with the EU GMP Annex-1 Revisions, the sterile facility will employ state-of-the-art V
HP isolation technology. It will specialise in GMP fill-finish for sterile drug products, encompassing both biologics and small molecules. The facility will leverage existing comprehensive capabilities in formulation development and quality control laboratories, supporting the manufacture of aseptic and terminally sterilised small-volume liquids for various delivery methods including parenteral, ocular, and pulmonary.
Construction of the facility is scheduled to commence in February 2024, with the aim of completing facility commissioning and validation by early Q4 of 2024.
This investment signifies an enhancement of Upperton’s current service offerings, which include formulation development for a wide range of dosage forms, clinical trial supply, and specialised commercial manufacturing for non-sterile dosage forms.
Nikki added, “Our leadership team is deeply aware of the challenges involved in advancing our clients from pre-clinical stages to the early phases of clinical studies, while maintaining a focus on quality and regulatory compliance. Our leadership’s extensive experience in sterile facility development and operations equips us to confidently enter this new market sector.”