UK contract development and manufacturing organization Upperton Pharma Solutions has completed the build of its new sterile manufacturing facility in Nottingham, UK.

The new purpose-built facility, which is in addition to the CDMO’s existing 50,000 sq. ft facility in Trent Gateway, was 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 formulations and pre-sterilized powders.

Nikki Whitfield, CEO, 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.

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.

While 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.