Upperton Pharma Solutions has completed the build of its new sterile manufacturing facility in Nottingham, UK, following its expansion for sterile fill–finish. Nikki Whitfield, CEO, Upperton Pharma Solutions, provided an update at the DCAT Member Company Announcement Forum at DCAT Week.  

The new facility is in addition to its existing 50,000-square-foot facility, 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 sterilized 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. 

The sterile facility will feature two cleanrooms with advanced vaporized hydrogen peroxide isolation technology and carry out GMP manufacturing of sterile drug products making use of existing full-service formulation development and quality control laboratories. 

The investment in sterile drug product manufacturing enhances the company’s 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. 

With the commissioning of the facility, along with the installation and validation of new equipment continues, Upperton will utilize 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.