NOTTINGHAM, UK. January 28th, 2025 – Leading UK contract development and manufacturing organisation (CDMO) Upperton Pharma Solutions, has completed the build of its new sterile manufacturing facility in Nottingham, UK.

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 which already develops and manufactures 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 at Upperton, 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 and Compliance at Upperton, 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 its research and development and analytical teams to support the pre-formulation and stability studies for early proof-of-concept products for parenteral, nasal and pulmonary delivery. 

ENDS

NOTTINGHAM, UK. July 16th, 2024 – Upperton Pharma Solutions, a contract development and manufacturing organisation (CDMO), is pleased to announce the successful completion of a Medicines and Healthcare products Regulatory Agency (MHRA) inspection at its newly commissioned 50,000 sq ft development and GMP manufacturing facility in Nottingham, UK.

This milestone inspection, conducted by the UK Government’s regulatory authority, marks a significant achievement for Upperton Pharma Solutions following the impressive completion of the build, commissioning, validation and approval of the facility in just 18 months. With the successful MHRA inspection approval, Upperton Pharma Solutions has further enhanced its offering, supporting the development of oral, nasal, and pulmonary drug products underpinned by the capability to provide Phase I, II, and III clinical supplies. 

Nikki Whitfield, CEO of Upperton Pharma Solutions, said: “We are absolutely delighted to achieve this milestone. We have been conducting manufacturing scale-up activities since the start of the year following the installation of the larger-scale solid oral dosage form process trains and this gives the green light for our GMP facility to support clients right through to late-phase clinical manufacture and product registration.”

The successful MHRA inspection enables Upperton Pharma Solutions to seamlessly transition from research and development (R&D) to GMP manufacturing and commercialisation on one site, following recent investment in large-scale process equipment including a Gerteis Mini-Pactor ®, GEA Post Hoist Blender, O’Hara M50 Tablet Coating System and a ZANASI 40 Capsule Filler.

Capable of handling batch sizes of up to 250kg and a wide variety of dosage forms, such as solids, liquids, semi-solids, nasal and inhaled pharmaceuticals, including potent molecules and controlled drugs, the MHRA approval signals Upperton’s transition into an integrated CDMO.  

Paul Kelsall, Director of Clinical Manufacturing, commented on the achievement, stating: “This is a dedication to the tremendous hard work our colleagues have put in to achieve the targets and aspirations of our business. We are looking forward to working with our clients and offering services from early-stage development through to late-stage clinical manufacture and Product Registration. These are exciting times for Upperton as we continue to move forward and expand our capabilities.”

Jon Austwick, Director of Quality & Compliance added: “This achievement is a culmination of 18 months of hard work to commission a state-of-the-art facility and build the rigorous quality and compliance processes to ensure the highest standards of service to our customers.”

ENDS