After completing the build and qualification of a new 50,000 sqft GMP facility during 2023, the UK-based CDMO announces further expansion at its Trent Gateway site to include sterile capabilities with a purpose-built facility designed specifically in line with the revised EU GMP Annex 1 regulations.
The £5m investment into an additional 7000 sqft sterile manufacturing facility at Trent Gateway, follows a period of significant growth in demand for the formulation development and manufacture of sterile and terminally sterilised products.
Nikki Whitfield, CEO of Upperton Pharma Solutions, said: “This investment addresses a real shortage within our industry of providers of small batches of sterile drug products to support early clinical trials."
"Given our existing formulation development and analytical capabilities, it represents a natural progression for Upperton and an exciting milestone in our growth plans.”
The sterile facility, designed in line with the EU GMP Annex-1 Revisions, will use advanced VHP isolation technology and do GMP fill-finish of sterile drug products for biologics and small molecules, making use of existing full-service formulation development and quality control labs.
The facility will support the manufacturing of aseptic and terminally sterilized small volume liquids for parenteral, ocular and pulmonary delivery.
The build is scheduled to begin in February 2024 with the facility commissioning and validation to be completed in early Q4 / 2024.
This investment in sterile drug product manufacturing enhances the existing service offering, which provides formulation development across a broad range of dosage forms, clinical trial supply and niche-scale commercial manufacture for non-sterile dosage forms.
Nikki added: “Our leadership team fully understands the challenges of getting our clients from preclinical to early phase clinical studies quickly, whilst maintaining quality and regulatory compliance."
"The combined experience of our leadership team in sterile facility builds and subsequent operations ensures that we will enter this new market with confidence.”
