A leading UK contract development and manufacturing organisation (CDMO) Upperton Pharma Solutions, has completed the build of its new sterile manufacturing facility in Nottingham.
The new facility is in addition to its existing 50,000 sq. ft facility, Trent Gateway, and the purpose-built facility has been designed specifically in line with the revised EU GMP Annex-1 regulations. The 7,000 sq. ft facility will support the manufacturing of aseptic and terminally sterilised small volume liquids and powders for parenteral, nasal and pulmonary delivery.
The new facility has the capability to support formulation development, clinical manufacture and analytical testing, with batch sizes of up to 2,000 vials, pre-filled syringes and pre-filled cartridges for liquid formulations and pre-sterilized powders.
The expansion is a natural progression for Upperton who already develop and manufacture small molecule and biological, non-sterile, oral, nasal and pulmonary dosage forms from early development to late-stage clinical manufacture for global biotech and pharmaceutical companies.
Nikki Whitfield, Chief Executive Officer, said: “We are delighted to complete the build of our sterile facility. The combined experience of our leadership team in sterile facility builds and subsequent operations ensures that we are ideally placed as a CDMO partner of choice for small to mid-sized biotech and pharma looking to get into the clinic quickly with fast access to sterile manufacturing services.”
The sterile facility will feature two cleanrooms with advanced VHP isolation technology and carry out GMP manufacturing of sterile drug products making use of existing full-service formulation development and quality control laboratories.
Jon Austwick, Director of Quality & Compliance, said: “This expansion illustrates our continued investment in our capabilities to support drug developers to scale and accelerate the path to delivering safe and effective medicines to patients. The facility has been built with the highest level of quality and is a testament to our internal teams and build vendor who have worked tirelessly over the past 12 months to bring our vision to life.”
This investment in sterile drug product manufacturing enhances the existing service offering from Upperton, which provides formulation development across a broad range of dosage forms, clinical trial supply, and late-stage manufacturing for non-sterile dosage forms for both small molecules and biologics.
Whilst the commissioning of the facility, along with the installation and validation of new equipment continues, Upperton will utilise existing expertise within their research & development and analytical teams to support the pre-formulation and stability studies for early proof-of concept products for parenteral, nasal and pulmonary delivery.