Cardiff University’s School of Pharmacy commissioned a feasibility study to scope the recommissioning of an existing building on their estate, for a new facility. This would bring together under one roof the work of several different schools and departments that currently contribute to the translation of viral vector research into gene therapy for the benefit of patients.
The aim of the new facility would be to enable the fast progression of novel therapeutic agents towards clinical trials, providing a versatile platform for developing clinically applicable cell and gene therapies for cancer, neurodegenerative and other diseases.
Our role:
CCTech worked closely with the project Steering Group to lead a Good Manufacturing Practice (GMP) Feasibility Study and engaged stakeholders to provide essential process and technical input. Steering Group members included Heads of Department, Heads of Facilities and Estates and key users.
Communication was managed through CCTech’s shared software platform which enabled Cardiff colleagues to access live and up to date information as the project progressed, to ensure that revisions of critical documents and meeting minutes were strictly managed and controlled.
The facility assessment and design requirements were led by a GMP buildings specialist, who assessed the condition of the current facility and determined the design changes necessary to accommodate the proposed new building use in order to achieve regulatory compliance.
CCTech led the development of the validation process by:
- Defining in detail what the facility and the processes within it were required to achieve.
- Using detailed questionnaires, the comprehensive business needs were identified, including outline block flows, batch sizes, and the requirements for quality control , equipment and the appropriate regulatory framework.
- The ‘testable attributes’ were defined to ensure the recommissioned facility would deliver the user requirements.
CCTech developed two proposal options that both met the project objectives but would result in different production capabilities and costs in support of the development of the business case. The two options were further discussed at workshops where stakeholders provided input for decision-making pertinent to the development of the new facilities.